Cheston Cold Syrup

Acetaminophen (Cheston Cold Syrup)® (Acetaminophen (Cheston Cold Syrup)) injection is indicated for

• the management of mild to moderate pain
• the management of moderate to severe pain with adjunctive opioid analgesics
• the reduction of fever.

Perennial Allergic Rhinitis: Cetirizine (Cheston Cold Syrup) hydrochloride syrup is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.

Chronic Urticaria: Cetirizine (Cheston Cold Syrup) hydrochloride syrup is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.

Temporary relief of symptoms of upper respiratory tract disorders such as sinusitis, vasomotor rhinitis, and hay fever; temporary relief of coughs associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma when tenacious mucus and/or mucus plugs and congestion complicate these conditions.

Acetaminophen (Cheston Cold Syrup) injection is used together with other medicines (eg, narcotic pain relievers) to relieve moderate to severe pain.

Acetaminophen (Cheston Cold Syrup) is used to relieve mild to moderate pain and reduce fever in patients. It does not become habit-forming when taken for a long time. Acetaminophen (Cheston Cold Syrup) may cause unwanted effects when taken in large doses, including liver damage.

Acetaminophen (Cheston Cold Syrup) is available only with your doctor's prescription.

Cetirizine (Cheston Cold Syrup) is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Cetirizine (Cheston Cold Syrup) is used to treat cold or allergy symptoms such as sneezing, itching, watery eyes, or runny nose.

Cetirizine (Cheston Cold Syrup) is also used to treat itching and swelling caused by chronic urticaria (hives).

Cetirizine (Cheston Cold Syrup) may also be used for purposes not listed in this medication guide.

Pseudoephedrine (Cheston Cold Syrup) (Pseudoephedrine (Cheston Cold Syrup)) is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Pseudoephedrine (Cheston Cold Syrup) is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

Pseudoephedrine (Cheston Cold Syrup) may also be used for purposes not listed in this medication guide.

General Dosing Information

Acetaminophen (Cheston Cold Syrup) may be given as a single or repeated dose for the treatment of acute pain or fever. No dose adjustment is required when converting between oral Acetaminophen (Cheston Cold Syrup) and Acetaminophen (Cheston Cold Syrup) dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of Acetaminophen (Cheston Cold Syrup) is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing Acetaminophen (Cheston Cold Syrup). Exceeding the maximum mg/kg daily dose of Acetaminophen (Cheston Cold Syrup) as described in Tables 1 and 2 may result in hepatic injury, including the risk of liver failure and death. To avoid the risk of overdose, ensure that the total amount of Acetaminophen (Cheston Cold Syrup) from all routes and from all credits does not exceed the maximum recommended dose.

Recommended

Dosage: Adults and Adolescents

Adults and adolescents weighing 50 kg and over: the recommended dosage of Acetaminophen (Cheston Cold Syrup) is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Acetaminophen (Cheston Cold Syrup) of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Cheston Cold Syrup) of 4000 mg per day (includes all routes of administration and all Acetaminophen (Cheston Cold Syrup)-containing products including combination products).

Adults and adolescents weighing under 50 kg: the recommended dosage of Acetaminophen (Cheston Cold Syrup) is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen (Cheston Cold Syrup) of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Cheston Cold Syrup) of 75 mg/kg per day (includes all routes of administration and all Acetaminophen (Cheston Cold Syrup)-containing products including combination products).

Table 1: Dosing for Adults and Adolescents

Recommended

Dosage: Children

Children 2 to 12 years of age: the recommended dosage of Acetaminophen (Cheston Cold Syrup) is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen (Cheston Cold Syrup) of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Cheston Cold Syrup) of 75 mg/kg per day.

Table 2: Dosing for Children

Instructions For

Intravenous Administration

For adult and adolescent patients weighing ≥ 50 kg requiring 1000 mg doses of Acetaminophen (Cheston Cold Syrup), administer the dose by inserting a vented intravenous set through the septum of the 100 mL vial. Acetaminophen (Cheston Cold Syrup) may be administered without further dilution. Examine the vial contents before dose preparation or administering. DO NOT USE if particulate matter or discoloration is observed. Administer the contents of the vial intravenously over 15-minutes. Use aseptic technique when preparing Acetaminophen (Cheston Cold Syrup) for intravenous infusion. Do not add other medications to the Acetaminophen (Cheston Cold Syrup) vial or infusion device.

For doses less than 1000 mg, the appropriate dose must be withdrawn from the vial and placed into a separate container prior to administration. Using aseptic technique, withdraw the appropriate dose (650 mg or weight-based) from an intact sealed Acetaminophen (Cheston Cold Syrup) vial and place the measured dose in a separate empty, sterile container (e.g. glass bottle, plastic intravenous container, or syringe) for intravenous infusion to avoid the inadvertent delivery and administration of the total volume of the commercially available container. The entire 100 mL vial of Acetaminophen (Cheston Cold Syrup) is not intended for use in patients weighing less than 50 kg. Acetaminophen (Cheston Cold Syrup) is a single-use vial and the unused portion must be discarded.

Place small volume pediatric doses up to 60 mL in volume in a syringe and administer over 15 minutes using a syringe pump.

Monitor the end of the infusion in order to prevent the possibility of an air embolism, especially in cases where the Acetaminophen (Cheston Cold Syrup) infusion is the primary infusion.

Once the vacuum seal of the glass vial has been penetrated, or the contents transferred to another container, administer the dose of Acetaminophen (Cheston Cold Syrup) within 6 hours.

Do not add other medications to the Acetaminophen (Cheston Cold Syrup) solution. Diazepam and chlorpromazine hydrochloride are physically incompatible with Acetaminophen (Cheston Cold Syrup), therefore do not administer simultaneously.

How supplied

Dosage Forms And Strengths

Acetaminophen (Cheston Cold Syrup) is a sterile, clear, colorless, non pyrogenic, preservative free, isotonic formulation of Acetaminophen (Cheston Cold Syrup) intended for intravenous infusion. Each 100 mL glass vial contains 1000 mg Acetaminophen (Cheston Cold Syrup) (10 mg/mL).

Storage And Handling

NDC 43825-102-01 - Acetaminophen (Cheston Cold Syrup)® (Acetaminophen (Cheston Cold Syrup)) Injection is supplied in a 100 mL glass vial containing 1000 mg Acetaminophen (Cheston Cold Syrup) (10 mg/mL) in cartons of 24 vials.

Acetaminophen (Cheston Cold Syrup) should be stored at 20°C to 25°C (68°F to 77°F).

For single use only. The product should be used within 6 hours after opening. Do not refrigerate or freeze.

Manufactured for: Mallinckrodt Hospital Products Inc., Hazelwood, MO 63042 USA. Revised: Dec 2014

Usual Adult Dose for Allergic Rhinitis

5 to 10 mg orally or chewed once a day

Usual Adult Dose for Urticaria

5 to 10 mg orally or chewed once a day

Usual Pediatric Dose for Allergic Rhinitis

6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.

2 to 5 years: 2.5 mg orally once a day, may be increased to 5 mg/day in 1 to 2 divided doses.

6 years or older: 5 to 10 mg orally or chewed once a day.

Usual Pediatric Dose for Urticaria

6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.

2 to 5 years: 2.5 mg orally once a day, may be increased to 5 mg/day in 1 to 2 divided doses.

6 years or older: 5 to 10 mg orally or chewed once a day.

Renal Dose Adjustments

CrCl less than 30 mL/min: 5 mg orally or chewed once a day.

Use of Cetirizine (Cheston Cold Syrup) is not recommended in children under 6 years of age with renal impairment due to the difficulty in reliably administering doses less than 2.5 mg (1/2 teaspoonful) and the lack of pharmacokinetic and safety information of Cetirizine (Cheston Cold Syrup) in such patients.

Liver Dose Adjustments

5 mg orally or chewed once a day

Use of Cetirizine (Cheston Cold Syrup) is not recommended in children under 6 years of age with hepatic impairment due to the difficulty in reliably administering doses less than 2.5 mg (1/2 teaspoonful) and the lack of pharmacokinetic and safety information of Cetirizine (Cheston Cold Syrup) in such patients.

Precautions

In clinical trials, the occurrence of somnolence has been reported. Due caution should therefore be exercised when driving a car or operating potential dangerous machinery. Concurrent use of alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

Dialysis

Cetirizine (Cheston Cold Syrup) is not significantly removed by hemodialysis, thus supplementary dosing is not required following hemodialysis. The recommended dosage for patients on hemodialysis is 5 mg orally or chewed once a day.

Usual Adult Dose for Nasal Congestion

Immediate release: 30 to 60 mg orally every 4 to 6 hours as needed

12-hour extended- release: 120 mg orally every 12 hours as needed

24-hour extended-release: 240 mg orally every 24 hours as needed

Maximum dose: 240 mg per day

Comment: Recommended doses should not be exceeded.

Uses:

-Temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies.

-Temporarily relieve sinus congestion and pressure.

Usual Pediatric Dose for Nasal Congestion

4 to 5 years:

Immediate release: 15 mg orally every 4 to 6 hours as needed

Maximum dose: 60 mg in 24 hours

6 to 12 years:

Immediate release: 30 mg orally every 4 to 6 hours as needed

Maximum dose: 120 mg in 24 hours

12 years or older:

Immediate release: 30 to 60 mg orally every 4 to 6 hours as needed

12-hour extended- release: 120 mg orally every 12 hours as needed

24-hour extended-release: 240 mg orally every 24 hours as needed

Maximum dose: 240 mg in 24 hours

Comments:

-Recommended doses should not be exceeded.

-Giving more than 1 cough and cold medicine to a child could result in overdose; there are many products that have similar names and it is critical to identify the active ingredients in the product to ensure the correct dosage is being used.

Uses:

-Temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies.

-Temporarily relieve sinus congestion and pressure.

Renal Dose Adjustments

Severe renal impairment: Use caution, especially in patients with concurrent cardiovascular disease.

Liver Dose Adjustments

Severe hepatic impairment: Use caution, especially in patients with concurrent cardiovascular disease.

Precautions

On March 9, 2006, The Combat Methamphetamine Epidemic Act of 2005 was enacted which requires sellers of this drug ensure that: employees have been trained; records of the training are being maintained; sales limits are being enforced; products are being stored appropriately; and a written or electronic logbook is being maintained. The law requires that retailers place Pseudoephedrine (Cheston Cold Syrup) products where customers do not have direct access to such products before a sale is made. The FDA defines Pseudoephedrine (Cheston Cold Syrup) as an OTC drug in accordance with the monograph and FDA regulations.

The US FDA strongly recommends that over- the- counter (OTC) cough and cold products not be used in children younger than 2 years of age because serious and potentially life-threatening side effects can occur including death, convulsions, rapid heart rates, and decreased levels of consciousness. OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives.

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Oral Liquid:

-Use only with enclosed measuring device or measuring devices specifically designed for measuring drugs.

Extended-release tablets:

-Swallow whole; do not divide crush, chew, or dissolve

Storage requirements:

-Protect from light

General:

-Over the counter cough and cold products can be harmful if more than the recommended amount is consumed; this may happen if more than 1 product containing the same active ingredient is used.

Patient advice:

-Patients should be instructed to pay close attention to drugs labels, particularly to the active ingredients section to ensure they are not receiving duplicate therapy.

-Adult cough and cold products should not be used for children; appropriate measuring devices should be used with liquid products.

-Patients should check with their health care provider if they are receiving concomitant medications.

-Patients should understand that over the counter cough and cold medications do not cure or shorten the duration of the common cold, these products are for the management of symptoms.

See also:
What is the most important information I should know about Acetaminophen (Cheston Cold Syrup)?

There are many brands and forms of Acetaminophen (Cheston Cold Syrup) available and not all brands are listed on this leaflet.

Do not take more of this medication than is recommended. An overdose of Acetaminophen (Cheston Cold Syrup) can damage your liver or cause death.

Know the amount of Acetaminophen (Cheston Cold Syrup) in the specific product you are taking.

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take Acetaminophen (Cheston Cold Syrup).

Avoid drinking alcohol. It may increase your risk of liver damage while taking Acetaminophen (Cheston Cold Syrup).

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (Cheston Cold Syrup) (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much Acetaminophen (Cheston Cold Syrup) which can lead to a fatal overdose. Check the label to see if a medicine contains Acetaminophen (Cheston Cold Syrup) or APAP.

See also:
What is the most important information I should know about Cetirizine (Cheston Cold Syrup)?

Tablet: Cetirizine (Cheston Cold Syrup) should not be used except under special circumstances for patients with hepatic and renal function impairment.

The risk-benefit should be considered when medical problems eg, bladder neck obstruction, prostatic hypertrophy, urinary retention and glaucoma exists.

Syrup: Hypersensitivity to Cetirizine (Cheston Cold Syrup) dihydrochloride, hydroxyzine, any piperazine derivatives or to any of the excipients of Cetirizine (Cheston Cold Syrup). Patients with severe renal impairment CrCl <10 mL/min. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Cetirizine (Cheston Cold Syrup).

See also:
What is the most important information I should know about Pseudoephedrine (Cheston Cold Syrup)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine (Cheston Cold Syrup) or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains Pseudoephedrine (Cheston Cold Syrup) or a decongestant.

Do not use Pseudoephedrine (Cheston Cold Syrup) if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Use Acetaminophen (Cheston Cold Syrup) injection as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Acetaminophen (Cheston Cold Syrup) injection is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Acetaminophen (Cheston Cold Syrup) injection at home, a health care provider will teach you how to use it. Be sure you understand how to use Acetaminophen (Cheston Cold Syrup) injection. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not mix other medicines (especially chlorpromazine or diazepam) in the same container or IV line as Acetaminophen (Cheston Cold Syrup) injection. Contact your health care provider if you have any questions about how to give Acetaminophen (Cheston Cold Syrup) injection with other medicines.
• Do not use Acetaminophen (Cheston Cold Syrup) injection if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Use Acetaminophen (Cheston Cold Syrup) injection within 6 hours after opening.
• If you miss a dose of Acetaminophen (Cheston Cold Syrup) injection and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen (Cheston Cold Syrup) injection.

Use Cetirizine (Cheston Cold Syrup) orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do not remove the blister unit from the carton until you are ready to take Cetirizine (Cheston Cold Syrup) orally disintegrating tablets. Make sure that your hands are dry when you open the blister unit. Do not push the tablet through the foil. Peel back the foil on the blister unit and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Cetirizine (Cheston Cold Syrup) orally disintegrating tablets may be taken with or without water. Take the tablet immediately after opening the blister unit. Do not store the removed tablet for future use.
• If you miss a dose of Cetirizine (Cheston Cold Syrup) orally disintegrating tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cetirizine (Cheston Cold Syrup) orally disintegrating tablets.

Use Pseudoephedrine (Cheston Cold Syrup) sustained-release tablets (24 hour) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pseudoephedrine (Cheston Cold Syrup) sustained-release tablets (24 hour) with food, water, or milk to minimize stomach irritation.
• Swallow Pseudoephedrine (Cheston Cold Syrup) sustained-release tablets (24 hour) whole. Do not break, crush, or chew before swallowing.
• Do not take more than 1 tablet in 24 hours.
• If you miss a dose of Pseudoephedrine (Cheston Cold Syrup) sustained-release tablets (24 hour) and are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pseudoephedrine (Cheston Cold Syrup) sustained-release tablets (24 hour).

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

How to use Acetaminophen (Cheston Cold Syrup) Extra Strength

Take this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

There are many brands and forms of Acetaminophen (Cheston Cold Syrup) available. Read the dosing instructions carefully for each product because the amount of Acetaminophen (Cheston Cold Syrup) may be different between products. Do not take more Acetaminophen (Cheston Cold Syrup) than recommended.

If you are giving Acetaminophen (Cheston Cold Syrup) to a child, be sure you use a product that is meant for children. Use your child's weight to find the right dose on the product package. If you don't know your child's weight, you can use their age.

For suspensions, shake the medication well before each dose. Some liquids do not need to be shaken before use. Follow all directions on the product package. Measure the liquid medication with the provided dose-measuring spoon/dropper/syringe to make sure you have the correct dose. Do not use a household spoon.

For rapidly-dissolving tablets, chew or allow to dissolve on the tongue, then swallow with or without water. For chewable tablets, chew thoroughly before swallowing.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

For effervescent tablets, dissolve the dose in the recommended amount of water, then drink.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.

Do not take this medication for fever for more than 3 days unless directed by your doctor. For adults, do not take this product for pain for more than 10 days (5 days in children) unless directed by your doctor. If the child has a sore throat (especially with high fever, headache, or nausea/vomiting), consult the doctor promptly.

Tell your doctor if your condition persists or worsens or if you develop new symptoms. If you think you may have a serious medical problem, get medical help right away.

This combination medication is used to treat tension headaches. Cetirizine (Cheston Cold Syrup) helps to decrease the pain from the headache. Caffeine helps increase the effects of Cetirizine (Cheston Cold Syrup). Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat migraine headaches.

How to use Cetirizine (Cheston Cold Syrup)

Take this medication by mouth with or without food as directed by your doctor, usually every 4 hours as needed.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition, age, and response to treatment. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Report any withdrawal reactions right away.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

Pseudoephedrine (Cheston Cold Syrup) is used for the temporary relief of stuffy nose and sinus pain/pressure caused by infection (such as the common cold, flu) or other breathing illnesses (such as hay fever, allergies, bronchitis). Pseudoephedrine (Cheston Cold Syrup) is a decongestant (sympathomimetic). It works by narrowing the blood vessels to decrease swelling and congestion.

If you are self-treating with this medication, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product in children younger than 6 years unless specifically directed by the doctor. Long-acting tablets/capsules are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar decongestants. Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Your doctor may direct you to use Pseudoephedrine (Cheston Cold Syrup) to decrease pain and swelling in the ear or to help "open up" the ear canal when there is a change in air pressure (such as during air travel, underwater diving). Follow your doctor's directions carefully.

How to use Pseudoephedrine (Cheston Cold Syrup)

If you are taking the over-the-counter product to self-treat, read all directions on the product package before taking this medication. If you have any questions, ask your doctor or pharmacist. If your doctor has prescribed this medication, take it as directed.

Take this medication by mouth with or without food, usually every 4-6 hours, as directed by the product package or by your doctor. Do not take more than 4 doses in a day. Dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or take this drug more often than directed. Do not take more of this medication than recommended for your age.

If you are using the chewable tablets, chew each tablet well and swallow. If you are using the liquid form of this medication, measure the dose carefully using a special measuring device/cup. Do not use a household spoon because you may not get the correct dose.

There are many brands and forms of Pseudoephedrine (Cheston Cold Syrup) available. Some tablets should be swallowed with plenty of water. Check your product package for specific directions. Read the dosing instructions carefully for each product because the amount of Pseudoephedrine (Cheston Cold Syrup) may be different between products. Do not take more Pseudoephedrine (Cheston Cold Syrup) than recommended.

Caffeine can increase the side effects of this medication. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas), eating large amounts of chocolate, or taking nonprescription products that contain caffeine.

If your symptoms do not improve after 7 days, if they worsen or return, if you develop fever, rash, or a persistent headache, or if you think you may have a serious medical problem, seek immediate medical attention.

See also:
What other drugs will affect Acetaminophen (Cheston Cold Syrup)?

Acetaminophen (Cheston Cold Syrup) is metabolized (eliminated by conversion to other chemicals) by the liver. Therefore drugs that increase the action of liver enzymes that metabolize Acetaminophen (Cheston Cold Syrup) [for example, carbamazepine (Tegretol), isoniazid (INH, Nydrazid, Laniazid), rifampin (Rifamate, Rifadin, Rimactane)] reduce the levels of Acetaminophen (Cheston Cold Syrup) and may decrease the action of Acetaminophen (Cheston Cold Syrup). Doses of Acetaminophen (Cheston Cold Syrup) greater than the recommended doses are toxic to the liver and may result in severe liver damage. The potential for Acetaminophen (Cheston Cold Syrup) to harm the liver is increased when it is combined with alcohol or drugs that also harm the liver.

Cholestyramine (Questran) reduces the effect of Acetaminophen (Cheston Cold Syrup) by decreasing its absorption into the body from the intestine. Therefore, Acetaminophen (Cheston Cold Syrup) should be administered 3 to 4 hours after cholestyramine or one hour before cholestyramine.

Acetaminophen (Cheston Cold Syrup) doses greater than 2275 mg per day may increase the blood thinning effect of warfarin (Coumadin) by an unknown mechanism. Therefore, prolonged administration or large doses of Acetaminophen (Cheston Cold Syrup) should be avoided during warfarin therapy

See also:
What other drugs will affect Cetirizine (Cheston Cold Syrup)?

Tablet: Concurrent use with alcohol may potentiate the CNS depressant effects of Cetirizine (Cheston Cold Syrup); maprotiline or tricyclic antidepressants may potentiate the anticholinergic effects of either these medications or Cetirizine (Cheston Cold Syrup).

Monoamine oxidase (MAO) inhibitors are not recommended because the use may prolong and intensify the anticholinergic and CNS depressant effects of Cetirizine (Cheston Cold Syrup).

Concurrent use with ototoxic medications may mask the symptoms of ototoxicity eg, tinnitus, dizziness or vertigo; photosensitizing medications may cause additive photosensitizing effects.

Syrup: No interaction is observed for Cetirizine (Cheston Cold Syrup) with pseudoephedrine, cimetidine, ketoconazole, erythromycin and azithromycin. Small decrease in Cetirizine (Cheston Cold Syrup) clearance is observed when theophylline (400 mg once daily) is taken with Cetirizine (Cheston Cold Syrup). However, disposition of theophylline was not altered by concomitant Cetirizine (Cheston Cold Syrup) administration. Concomitant administration of Cetirizine (Cheston Cold Syrup) and macrolides or ketoconazole has never resulted clinically relevant EGG changes. Extent of exposure to Cetirizine (Cheston Cold Syrup) was increased by 40% when ritonavir is taken with Cetirizine (Cheston Cold Syrup). Disposition of ritonavir was slightly altered further to concomitant Cetirizine (Cheston Cold Syrup) administration.

See also:
What other drugs will affect Pseudoephedrine (Cheston Cold Syrup)?

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: stimulants (such as caffeine, dextroamphetamine, methamphetamine, herbal products like ephedra/ma huang), terbutaline.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Pseudoephedrine (Cheston Cold Syrup) may decrease the effectiveness of blood pressure medications (such as beta blockers, calcium channel blockers, reserpine, guanethidine, methyldopa).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain similar ingredients (decongestants such as phenylephrine). Ask your pharmacist about using those products safely.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

See also:
What are the possible side effects of Acetaminophen (Cheston Cold Syrup)?

Applies to Acetaminophen (Cheston Cold Syrup): capsule, capsule liquid filled, elixir, liquid, powder, powder for solution, solution, suppository, suspension, syrup, tablet, tablet chewable, tablet disintegrating, tablet effervescent, tablet extended release

Other dosage forms:

• intravenous solution

Along with its needed effects, Acetaminophen (Cheston Cold Syrup) (the active ingredient contained in Acetaminophen (Cheston Cold Syrup)) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking Acetaminophen (Cheston Cold Syrup):

Rare

• Bloody or black, tarry stools
• bloody or cloudy urine
• fever with or without chills (not present before treatment and not caused by the condition being treated)
• pain in the lower back and/or side (severe and/or sharp)
• pinpoint red spots on the skin
• skin rash, hives, or itching
• sore throat (not present before treatment and not caused by the condition being treated)
• sores, ulcers, or white spots on the lips or in the mouth
• sudden decrease in the amount of urine
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking Acetaminophen (Cheston Cold Syrup):

Symptoms of overdose

• Diarrhea
• increased sweating
• loss of appetite
• nausea or vomiting
• stomach cramps or pain
• swelling, pain, or tenderness in the upper abdomen or stomach area

See also:
What are the possible side effects of Cetirizine (Cheston Cold Syrup)?

Pediatric studies were conducted with Cetirizine (Cheston Cold Syrup) hydrochloride. More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with Cetirizine (Cheston Cold Syrup) hydrochloride at doses of 1.25 to 10 mg per day were included in controlled and uncontrolled clinical trials conducted in the United States. The duration of treatment ranged from 2 to 12 weeks. Placebo-controlled trials up to 4 weeks duration included 168 pediatric patients aged 2 to 5 years who received Cetirizine (Cheston Cold Syrup), the majority of whom received single daily doses of 5 mg. A placebo-controlled trial 18 months in duration included 399 patients aged 12 to 24 months treated with Cetirizine (Cheston Cold Syrup) (0.25 mg/kg bid), and another placebo-controlled trial of 7 days duration included 42 patients aged 6 to 11 months who were treated with Cetirizine (Cheston Cold Syrup) (0.25 mg/kg bid).

The majority of adverse reactions reported in pediatric patients aged 2 to 11 years with Cetirizine (Cheston Cold Syrup) hydrochloride were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in pediatric patients receiving up to 10 mg of Cetirizine (Cheston Cold Syrup) hydrochloride was uncommon (0.4% on Cetirizine (Cheston Cold Syrup) hydrochloride vs. 1.0% on placebo).

Table 1 lists adverse experiences which were reported for Cetirizine (Cheston Cold Syrup) hydrochloride 5 and 10 mg in pediatric patients aged 6 to 11 years in placebo-controlled clinical trials in the United States and were more common with Cetirizine (Cheston Cold Syrup) hydrochloride than placebo. Of these, abdominal pain was considered treatment-related and somnolence appeared to be dose-related, 1.3% in placebo, 1.9% at 5 mg and 4.2% at 10 mg. The adverse experiences reported in pediatric patients aged 2 to 5 years in placebo-controlled trials were qualitatively similar in nature and generally similar in frequency to those reported in trials with children aged 6 to 11 years.

In the placebo-controlled trials of pediatric patients 6 to 24 months of age, the incidences of adverse experiences, were similar in the Cetirizine (Cheston Cold Syrup) and placebo treatment groups in each study. Somnolence occurred with essentially the same frequency in patients who received Cetirizine (Cheston Cold Syrup) hydrochloride and patients who received placebo. In a study of 1 week duration in children 6 to 11 months of age, patients who received Cetirizine (Cheston Cold Syrup) exhibited greater irritability/fussiness than patients on placebo. In a study of 18 months duration in patients 12 months and older, insomnia occurred more frequently in patients who received Cetirizine (Cheston Cold Syrup) compared to patients who received placebo (9.0% v. 5.3%). In those patients who received 5 mg or more per day of Cetirizine (Cheston Cold Syrup) as compared to patients who received placebo, fatigue (3.6% v. 1.3%) and malaise (3.6% v. 1.8%) occurred more frequently.

Table 1.

Adverse Experiences Reported in Pediatric Patients Aged 6 to 11 Years in Placebo-Controlled United States Cetirizine (Cheston Cold Syrup) Hydrochloride Trials (5 or 10 mg Dose) Which Occurred at a Frequency of ≥2% in Either the 5-mg or the 10-mg Cetirizine (Cheston Cold Syrup) Hydrochloride Group, and More Frequently Than in the Placebo Group

The following events were observed infrequently (less than 2%), in either 3982 adults and children 12 years and older or in 659 pediatric patients aged 6 to 11 years who received Cetirizine (Cheston Cold Syrup) hydrochloride in U.S. trials, including an open adult study of six months duration. A causal relationship of these infrequent events with Cetirizine (Cheston Cold Syrup) hydrochloride administration has not been established.

Autonomic Nervous System: anorexia, flushing, increased salivation, urinary retention.

Cardiovascular: cardiac failure, hypertension, palpitation, tachycardia.

Central and Peripheral Nervous Systems: abnormal coordination, ataxia, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, leg cramps, migraine,

myelitis, paralysis, paresthesia, ptosis, syncope, tremor, twitching, vertigo, visual field defect.

Gastrointestinal: abnormal hepatic function, aggravated tooth caries, constipation, dyspepsia, eructation, flatulence, gastritis, hemorrhoids, increased appetite, melena, rectal hemorrhage, stomatitis including ulcerative stomatitis, tongue discoloration, tongue edema.

Genitourinary: cystitis, dysuria, hematuria, micturition frequency, polyuria, urinary incontinence, urinary tract infection.

Hearing and Vestibular: deafness, earache, ototoxicity, tinnitus.

Metabolic/Nutritional: dehydration, diabetes mellitus, thirst.

Musculoskeletal: arthralgia, arthritis, arthrosis, muscle weakness, myalgia.

Psychiatric: abnormal thinking, agitation, amnesia, anxiety, decreased libido, depersonalization, depression, emotional lability, euphoria, impaired concentration, insomnia, nervousness, paroniria, sleep disorder.

Respiratory System: bronchitis, dyspnea, hyperventilation, increased sputum, pneumonia, respiratory disorder, rhinitis, sinusitis, upper respiratory tract infection.

Reproductive: dysmenorrhea, female breast pain, intermenstrual bleeding, leukorrhea, menorrhagia, vaginitis.

Reticuloendothelial: lymphadenopathy.

Skin: acne, alopecia, angioedema, bullous eruption, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, hypertrichosis, increased sweating, maculopapular rash, photosensitivity reaction, photosensitivity toxic reaction, pruritus, purpura, rash, seborrhea, skin disorder, skin nodule, urticaria.

Special Senses: parosmia, taste loss, taste perversion.

Vision: blindness, conjunctivitis, eye pain, glaucoma, loss of accommodation, ocular hemorrhage, xerophthalmia.

Body as a Whole: accidental injury, asthenia, back pain, chest pain, enlarged abdomen, face edema, fever, generalized edema, hot flashes, increased weight, leg edema, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral edema, rigors.

Occasional instances of transient, reversible hepatic transaminase elevations have occurred during Cetirizine (Cheston Cold Syrup) therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of Cetirizine (Cheston Cold Syrup) hydrochloride has been reported.

Post-Marketing Experience

In the post-marketing experience period, the following additional rare, but potentially severe adverse events have been reported: aggressive reaction, anaphylaxis, cholestasis, convulsions, glomerulonephritis, hallucinations, hemolytic anemia, hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, suicidal ideation, suicide and thrombocytopenia.

See also:
What are the possible side effects of Pseudoephedrine (Cheston Cold Syrup)?

Applies to Pseudoephedrine (Cheston Cold Syrup): oral capsule, oral capsule extended release, oral capsule liquid filled, oral liquid, oral solution, oral suspension, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release

Along with its needed effects, Pseudoephedrine (Cheston Cold Syrup) (the active ingredient contained in Pseudoephedrine (Cheston Cold Syrup)) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking Pseudoephedrine (Cheston Cold Syrup):

Rare

• Convulsions (seizures)
• hallucinations (seeing, hearing, or feeling things that are not there)
• irregular or slow heartbeat
• shortness of breath or troubled breathing

Symptoms of Overdose

• Convulsions (seizures)
• fast breathing
• hallucinations (seeing, hearing, or feeling things that are not there)
• increase in blood pressure
• irregular heartbeat (continuing)
• shortness of breath or troubled breathing (severe or continuing)
• slow or fast heartbeat (severe or continuing)
• unusual nervousness, restlessness, or excitement

Some side effects of Pseudoephedrine (Cheston Cold Syrup) may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

• Nervousness
• restlessness
• trouble in sleeping

Less Common

• Difficult or painful urination
• dizziness or light-headedness
• fast or pounding heartbeat
• headache
• increased sweating
• nausea or vomiting
• trembling
• unusual paleness
• weakness

Acetaminophen (Cheston Cold Syrup) (with the Optizorb formulation) also contains the following excipients: Pregelatinized maize starch, calcium carbonate, alginic acid, crospovidone, povidone, magnesium stearate, colloidal anhydrous silica, parahydroxybenzoates (sodium methyl, ethyl and propyl), OPADRY YS-1-7003 white, carnauba wax, purified water.

It contains no sugar, lactose or gluten.

Cetirizine (Cheston Cold Syrup) HCl is a piperazine derivative and a metabolite of hydroxyzine. It competes reversibly with histamine to block the histamine (H₁) receptor sites. Cetirizine (Cheston Cold Syrup) HCl is considered a long-acting nonsedating antihistamine and has some mast-cell stabilizing activity.

Pseudoephedrine (Cheston Cold Syrup) has been withdrawn in Canada. In November 2000, the Food and Drug Administration (FDA) issued a public health advisory against the use of the drug.