Sinus 77

Sinus 77 is indicated for symptomatic relief of the coryza and nasal congestion associated with the common cold, sinusitis, allergic rhinitis and other upper respiratory tract conditions. Appropriate therapy should be provided for the primary disease.

Sinus 77 contains a combination of Chlorpheniramine (Sinus 77) and Phenylephrine (Sinus 77). Chlorpheniramine (Sinus 77) is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Phenylephrine (Sinus 77) is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Sinus 77 is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Sinus 77 may also be used for other purposes not listed in this medication guide.

Adults and Children 12 years of age and older: 1 teaspoonful (5mL) every 4 to 6 hours, not to exceed 6 teaspoonsful in 24 hours. Children 6 to under 12 years of age: 1/2 teaspoonful every 4 to 6 hours, not to exceed 3 teaspoonsful in 24 hours. Children 2 to under 6 years of age: 1/4 teaspoonful every 4 to 6 hours, not to exceed 1.5 teaspoonsful in 24 hours. Not recommended for use in children under 2 years of age.

In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate.

How supplied

Sinus 77® Syrup (carbinoxamine maleate and pseudoephedrine hcl) is a sugar-free, alcohol-free, bubble gum-flavored syrup available in bottles of 16 fluid ounces (473 mL), NDC 68188-061-16; bottles of 4 fluid ounces (118 mL), NDC 68188-061-04; and bottles of 20 mL, NDC 68188-061-20.

Storage Requirements

Store at Controlled Room Temperature between 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Avoid exposure to heat. Keep tightly closed.

Dispense in USP tight, light-resistant container with child resistant closure.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Manufactured for: Alliant Pharmaceuticals, Inc., Alpharetta, GA 30022 USA. Rev. 09/05.

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What is the most important information I should know about Sinus 77?

Sinus 77 is contraindicated in patients with hypersensitivity or idiosyncrasy to any of its ingredients, patients taking monoamine oxidase (MAO) inhibitors or for two weeks after stopping the MAOI drug, patients with narrow-angle glaucoma, severe coronary artery disease, urinary retention, peptic ulcer, severe hypertension, patients with breathing problems such as emphysema or chronic bronchitis, or nursing mothers.

Use Sinus 77 controlled-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Sinus 77 controlled-release tablets may be taken with or without food.
• Swallow Sinus 77 controlled-release tablets whole. Do not break, crush, or chew before swallowing. Some brands of Sinus 77 controlled-release tablets may be broken in half before they are taken. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand may be broken in half.
• If you miss a dose of Sinus 77 controlled-release tablets, 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 Sinus 77 controlled-release tablets.

This combination medication is used to temporarily relieve symptoms caused by the common cold, flu, allergies, or other breathing illnesses (such as sinusitis, bronchitis). Antihistamines help relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. Decongestants help to relieve stuffy nose and ear congestion symptoms.

If you are self-treating with this medication, carefully read the package instructions to be sure it is right for you before you start using this product. Some products have similar brand names but different active ingredients with different uses. Taking the wrong product could harm you. Ask your pharmacist if you have any questions about your product or its use.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (including some 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. Do not use this product to make a child sleepy.

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 give other cough-and-cold medication that might contain the same or similar ingredients. 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).

How to use Sinus 77

Take this medication by mouth as directed by your doctor. If you are self-treating, follow all directions on the product package. If you are uncertain about any of the information, ask your doctor or pharmacist.

This medication may be taken with food if stomach upset occurs. Drink plenty of fluids unless otherwise directed by your doctor.

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. If your liquid form is a suspension, shake the bottle well before each dose.

Do not crush or chew extended-release tablets or capsules. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split extended-release 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.

If you are using chewable tablets, chew each tablet thoroughly before swallowing.

If you are using a product made to dissolve in the mouth (tablets/strips), dry your hands before handling the medication. Place each dose on the tongue and allow to dissolve completely, then swallow it with saliva or with water.

Dosage is based on the product you are taking and your age, medical condition, and response to treatment. Do not increase your dose or take this medication more often than directed without your doctor's approval. Improper use (abuse) of this medication may result in serious harm (such as hallucinations, seizure, death).

If your doctor directs you to take this medication daily, take it regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Tell your doctor if your condition persists for more than 1 week, if it worsens, or if it occurs with fever, rash, or persistent headache. These may be symptoms of a serious medical problem and should be checked by a doctor.

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What other drugs will affect Sinus 77?

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: antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), blood pressure medications (especially reserpine, guanethidine, methyldopa, beta blockers such as atenolol, or calcium channel blockers such as nifedipine).

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.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as cough-and-cold products, diet aids) because they may contain ingredients that could affect your blood pressure or cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain medical/laboratory tests (including brain scan for Parkinson's disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

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.

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What are the possible side effects of Sinus 77?

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Adverse effects associated with Sinus 77 at recommended doses have been minimal. The most common have been drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines or sympathomimetics have been rare.