Benzonatate/Diphenhydramine Hcl/Guaiphenesin/Phenylephrine Hcl

Benzonatate is a medication taken orally to suppress coughs. It has an anesthetic (numbing) action similar to that of benzocaine and "numbs" the stretch sensors in the lungs. It is the stretching of these sensors with breathing that causes the cough. Benzonatate begins to work within 15 to 20 minutes, and its effects last for approximately 3 hours. Benzonatate is unrelated to narcotics such as codeine which are frequently used to suppress coughs. (Another frequently used cough suppressant, dextromethorphan, which is found in many over-the-counter cough and cold preparations, is a derivative of the narcotics.) Benzonatate was approved by the FDA in 1958.

Relief of symptoms associated w/ seasonal, perennial, vasomotor rhinitis; allergic conjunctivitis; mild, uncomplicated allergic skin manifestations of urticaria & angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; anaphylactic reactions adjunctive to epinephrine & other standard measures after acute manifestations have been controlled. Management of parkinsonism (including drug-induced) in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism (including drug-induced) in other age groups; in other cases of parkinsonism (including drug-induced) in combination w/ centrally acting anticholinergics. Short-term management of insomnia. Relief of cough caused by minor throat & bronchial irritation. Prevention & treatment of nausea, vomiting, &/or dizziness associated w/ motion sickness.

Helps loosen phlegm & helps clear chest congestion.

Phenylephrine Hcl is used for the temporary relief of stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, or other breathing illnesses (e.g., sinusitis, bronchitis). This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe.

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 (such as 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.

Benzonatate is used to relieve coughs due to colds or influenza (flu). It is not to be used for chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm with the cough.

Benzonatate relieves cough by acting directly on the lungs and the breathing passages. It may also act on the cough center in the brain.

benzonatate is available only with your doctor's prescription.

Diphenhydramine Hcl 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.

Diphenhydramine Hcl is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms.

Diphenhydramine Hcl is also used to treat motion sickness, to induce sleep, and to treat certain symptoms of Parkinson's disease.

Diphenhydramine Hcl may also be used for purposes not listed in this medication guide.

Phenylephrine Hcl (Phenylephrine Hcl) is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Phenylephrine Hcl 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.

Phenylephrine Hcl may also be used for purposes not listed in this medication guide.

Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate Capsules should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.

How supplied

Benzonatate capsules USP, 100 mg are light yellow-colored, round-shaped soft gelatin capsules, imprinted with “Z” containing pale yellow-colored clear viscous liquid and are supplied as follows:

NDC 65841-614-01 in bottle of 100 capsules

NDC 65841-614-05 in bottle of 500 capsules

Benzonatate capsules USP, 200 mg are light yellow-colored, round-shaped soft gelatin capsules, imprinted with “β” containing pale yellow-colored clear viscous liquid and are supplied as follows:

NDC 65841-615-01 in bottle of 100 capsules

Store at 20° - 25°C (68° - 77°F).

Dispense in a tight, light-resistant container.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Revised: 11/03/2011

Oral, IV, IM, rectal, topical, intranasal, in the conjunctival sac.

Oral dose of Diphenhydramine Hcl for adults is 30-50 mg 1-3 times / day. The treatment course is 10-15 days. As soporific - 50 mg at bedtime. IM in doses of 50-250 mg; IV in drip - 20-50 mg. When oral administered single dose for children under 1 year - 2-5 mg; from 2 to 5 years - 5-15 mg; of 6 to 12 years - 15-30 mg. Externally applied 1-2 times / day.

Adult & childn >12 yr 10-20 mL. Childn 6-12 yr 5-10 mL. To be taken 4 hrly. Max: 6 doses/24 hr.

Usual Adult Dose for Hypotension:

IM or subcutaneous: 2 to 5 mg every 1 to 2 hours as needed.

IV bolus: 0.2 mg/dose (range: 0.1 to 0.5 mg/dose) every 10 to 15 minutes as needed (initial dose should not exceed 0.5 mg)

IV infusion: 100 to 180 mcg/min initially. The usual maintenance dose is 40 to 60 mcg/min.

Alternatively, 0.5 mcg/kg/minute; titrate to desired response. Dosing ranges between 0.4 to 9.1 mcg/kg/minute have been reported.

Usual Adult Dose for Shock:

IM or subcutaneous: 2 to 5 mg every 1 to 2 hours as needed.

IV bolus: 0.2 mg/dose (range: 0.1 to 0.5 mg/dose) every 10 to 15 minutes as needed (initial dose should not exceed 0.5 mg)

IV infusion: 100 to 180 mcg/min initially. The usual maintenance dose is 40 to 60 mcg/min.

Alternatively, 0.5 mcg/kg/minute; titrate to desired response. Dosing ranges between 0.4 to 9.1 mcg/kg/minute have been reported.

Usual Adult Dose for Supraventricular Tachycardia:

0.25 to 0.5 mg IV over 30 seconds.

Usual Adult Dose for Nasal Congestion:

Tablets or oral liquid: 10 to 20 mg orally every 4 hours as needed.

Phenylephrine Hcl 7.5 mg/5 mL oral liquid:

15 mg orally every 6 hours not to exceed 60 mg daily.

Phenylephrine Hcl 10 mg oral tablet:

10 mg orally every 4 to 6 hours not to exceed 4 doses daily.

Phenylephrine Hcl 10 mg oral disintegrating strip:

10 mg orally every 4 hours not to exceed 6 doses daily.

Phenylephrine Hcl 10 mg/5 mL oral suspension, extended release:

10 to 20 mg orally every 12 hours.

Phenylephrine Hcl tannate 10 mg oral tablet, chewable, extended release:

10 to 20 mg orally every 12 hours.

Phenylephrine Hcl tannate 7.5 mg/5 mL oral suspension, extended release

7.5 to 15 mg orally every 12 hours.

Usual Pediatric Dose for Hypotension:

IM or subcutaneous: 0.1 mg/kg every 1 to 2 hours as needed. Maximum dose: 5 mg.

IV bolus: 5 to 20 mcg/kg/dose every 10 to 15 minutes as needed.

IV: 0.1 to 0.5 mcg/kg/min titrated to effect.

Usual Pediatric Dose for Shock:

IM or subcutaneous: 0.1 mg/kg every 1 to 2 hours as needed. Maximum dose: 5 mg.

IV bolus: 5 to 20 mcg/kg/dose every 10 to 15 minutes as needed.

IV: 0.1 to 0.5 mcg/kg/min titrated to effect.

Usual Pediatric Dose for Supraventricular Tachycardia:

5 to 10 mcg/kg IV over 30 seconds.

Usual Pediatric Dose for Nasal Congestion:

Phenylephrine Hcl 1.25 mg/0.8 mL oral liquid:

2 years to 5 years: 1.6 mL orally every 4 hours not to exceed 6 doses daily.

Chewable tablets or oral liquid:

6 years to 11 years: 10 mg orally every 4 hours as needed.

12 years or older: 10 to 20 mg orally every 4 hours as needed.

Phenylephrine Hcl 7.5 mg/5 mL oral liquid:

2 years to 5 years: 3.75 mg orally every 6 hours not to exceed 15 mg daily.

6 years to 11 years: 7.5 mg orally every 6 hours not to exceed 30 mg daily.

12 years or older: 15 mg orally every 6 hours not to exceed 60 mg daily.

Phenylephrine Hcl 10 mg oral tablet:

12 years or older: 10 mg orally every 4 to 6 hours not to exceed 4 doses daily.

Phenylephrine Hcl 10 mg oral tablet, disintegrating:

2 years to 5 years: 5 mg orally every 4 hours as needed.

6 years to 11 years: 10 mg orally every 4 hours as needed.

12 years or older: 10 to 20 mg orally every 4 hours as needed.

Phenylephrine Hcl 10 mg/5 mL oral suspension, extended release:

12 years or older: 10 to 20 mg orally every 12 hours.

6 years to 11 years: 5 to 10 mg orally every 12 hours.

Phenylephrine Hcl 10 mg oral disintegrating strip:

12 years or older: 10 mg orally every 4 hours not to exceed 6 doses daily.

Phenylephrine Hcl tannate 10 mg oral tablet, chewable, extended release:

6 years to 11 years: 5 to 10 mg orally every 12 hours.

12 years or older: 10 to 20 mg orally every 12 hours.

Phenylephrine Hcl tannate 7.5 mg/5 mL oral suspension, extended release

2 years to 5 years: 1.25 to 2.5 mL orally every 12 hours.

6 years to 11 years: 2.5 to 5 mL orally every 12 hours.

12 years or older: 5 to 10 mL orally every 12 hours.

Phenylephrine Hcl 1.25 mg oral disintegrating strip:

2 years to 3 years: 2.5 mg orally every 4 hours, not to exceed 15 mg in 24 hours.

Phenylephrine Hcl 2.5 mg oral disintegrating strip:

2 years to 5 years: 2.5 mg orally every 4 hours, not to exceed 15 mg in 24 hours.

6 years to 11 years: 5 mg orally every 4 hours, not to exceed 30 mg in 24 hours.

Phenylephrine Hcl 1.25 mg oral tablet, chewable:

12 years or older: 5 mg orally every 4 hours not to exceed 6 doses daily.

Phenylephrine Hcl 2.5 mg/5 mL oral liquid:

4 years to 5 years: 5 mL orally every 4 hours, not to exceed 6 doses in 24 hours.

6 years to 11 years: 10 mL orally every 4 hours, not to exceed 6 doses in 24 hours.

See also:
What is the most important information I should know about Benzonatate?

You should not use this medication if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams).

Never suck or chew on a benzonatate capsule. Swallow the pill whole. Sucking or chewing the capsule may cause your mouth and throat to feel numb or cause other serious side effects.

Serious side effects of benzonatate include choking feeling, chest pain or numbness, feeling like you might pass out, confusion, or hallucinations. Some of these side effects may result from chewing or sucking on a benzonatate capsule.

Do not give this medication to a child younger than 10 years old without medical advice. An overdose of benzonatate can be fatal to a child.

See also:
What is the most important information I should know about Diphenhydramine Hcl?

Hypersensitivity to Diphenhydramine Hcl HCl and other antihistamines of similar chemical structure; monoamine oxidase inhibitor therapy.

Use in Newborn or Premature Infants: Diphenhydramine Hcl should not be used in newborn or premature infants.

Use in Lower Respiratory Disease: Antihistamine should not be used to treat lower respiratory tract symptom including asthma.

Use in Lactation: Generally, because of the higher risk of antihistamines for infants, newborns and prematures in particular, antihistamine therapy is contraindicated in breastfeeding mothers.

Guaiphenesin Tablets are contraindicated in patients hypersensitive to any of the ingredients.

See also:
What is the most important information I should know about Phenylephrine Hcl?

Hypersensitivity to any component of the products, potassium guaiacolsulfonate, or to sympathomimetic amines; severe hypertension; ventricular tachycardia; pheochromocytoma; ophthalmic 10% solution contraindicated in infants and patients with aneurysms; low birth weight infants; anatomically narrow angles or narrow-angle glaucoma; during intraocular procedures when the corneal epithelial barrier has been disrupted; elderly patients with severe arteriosclerotic CV or cerebrovascular disease; MAOI use or 14 days after stopping an MAOI; severe coronary artery disease.

Use Benzonatate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Benzonatate by mouth with or without food.
• Swallow Benzonatate whole. Do not break, crush, chew, dissolve, or suck on Benzonatate before swallowing.
• If you miss a dose of Benzonatate, 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 Benzonatate.

Use Diphenhydramine Hcl as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Diphenhydramine Hcl by mouth with or without food.
• Do not remove the strip from the pouch until you are ready to take Diphenhydramine Hcl. Make sure that your hands are dry when you open Diphenhydramine Hcl. Remove and place the strip on the tongue. The strip dissolves quickly (and it can be swallowed with saliva). Diphenhydramine Hcl may be taken with or without water. Take the strip immediately after opening the pouch. Do not store the strip for future use.
• Use Diphenhydramine Hcl exactly as directed on the package, unless instructed differently by your doctor. If you are taking Diphenhydramine Hcl without a prescription, follow any warnings and precautions on the label.
• If you miss a dose of Diphenhydramine Hcl 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 Diphenhydramine Hcl.

Use Phenylephrine Hcl as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Phenylephrine Hcl is for use in the eye only. Avoid contact with the nose or mouth.
• To use Phenylephrine Hcl, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including your eye. Keep the container tightly closed.
• Do not wear contact lenses while you are using Phenylephrine Hcl. Sterilize contact lenses according to the manufacturer's directions and check with your doctor before using them.
• Do not use Phenylephrine Hcl if it is brown or contains particles.
• If you miss a dose of Phenylephrine Hcl, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Phenylephrine Hcl.

Use: Labeled Indications

Cough: Symptomatic relief of cough

Diphenhydramine Hcl injection is an antihistamine used to treat life-threatening allergic reactions (anaphylaxis) along with epinephrine and other treatments. It is also used to relieve symptoms of household allergies, hay fever and the common cold when medication cannot be given by mouth. Common allergy symptoms relieved by antihistamines include rash, itching, watery eyes, itchy eyes/nose/throat, cough, runny nose and sneezing.

It is also used to treat nausea, vomiting and dizziness caused by motion sickness when medication cannot be given by mouth. Diphenhydramine Hcl works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its drying effects on such symptoms as watery eyes and runny nose are caused by blocking another natural substance made by your body (acetylcholine).

Diphenhydramine Hcl should not be used in newborns or premature infants because of an increased risk of side effects.

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.

Diphenhydramine Hcl injection is also used alone or with other medications to treat shaking (tremor) and muscle stiffness caused by Parkinson's disease when medication cannot be given by mouth. It may also be used to treat side effects of certain psychiatric drugs such as involuntary movements and muscle stiffness (e.g., EPS). It works by blocking acetylcholine.

How to use Diphenhydramine Hcl injection

This medication is injected into a vein (IV) no faster than 25 milligrams per minute, or deeply into a muscle as directed by your doctor. Be very careful to inject into a vein or muscle and not into the skin or just under the skin. If this medication is injected into or just under the skin, it can destroy the skin and tissues around the injection site (necrosis).

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Do not use this medication more often than prescribed. Your dosage is based on your medical condition and response to therapy. Inform your doctor if your condition does not improve or if it worsens.

Phenylephrine Hcl is used for the temporary relief of stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, or other breathing illnesses (e.g., sinusitis, bronchitis). This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe.

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 (such as 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 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 Phenylephrine Hcl

If you are using the over-the-counter product, read and follow all directions on the product package before taking this medication.

Take this medication by mouth with or without food or as directed by your doctor. Taking it with food may decrease stomach upset.

If you are using the liquid, carefully measure your prescribed dose using a medication-measuring device or spoon. Do not use a household spoon because you may not get the correct dose.

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 or 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.

The dosage is based on your age. 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 (e.g., hallucinations, seizure, death).

If your symptoms worsen or do not improve after 7 days, if you develop fever/chills, or if you think you may have a serious medical problem, seek immediate medical attention.

See also:
What other drugs will affect Benzonatate?

There are no known drug interactions with benzonatate.

See also:
What other drugs will affect Diphenhydramine Hcl?

When Diphenhydramine Hcl applied simultaneously increases the effects of ethanol and drugs that depress the central nervous system.

With simultaneous use of Diphenhydramine Hcl and MAO inhibitors increase the anticholinergic activity of Diphenhydramine Hcl.

The antagonistic interaction observed with a joint appointment with psychostimulants.

Reduces the effectiveness of apomorphine as an emetic in the treatment of poisoning. Intensifies anticholinergic effects of drugs with anticholinergic activity.

No information available.

See also:
What other drugs will affect Phenylephrine Hcl?

If you are taking this product under your doctor's direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

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.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting the nasal decongestant.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: high blood pressure medications (e.g., reserpine, guanethidine), tricyclic antidepressants (e.g., amitriptyline).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain decongestants or ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about using those products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

See also:
What are the possible side effects of Benzonatate?

Applies to benzonatate: oral capsule, oral capsule liquid filled

As well as its needed effects, benzonatate (the active ingredient contained in Benzonatate) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking benzonatate, check with your doctor immediately:

Rare

• Confusion
• difficult breathing
• difficulty with speaking
• seeing things that are not there
• shortness of breath
• tightness in the chest
• wheezing

If any of the following symptoms of overdose occur while taking benzonatate, get emergency help immediately:

Symptoms of overdose:

• Change in consciousness
• convulsions (seizures)
• loss of consciousness
• no blood pressure or pulse
• restlessness
• shakiness in the legs, arms, hands, or feet
• stopping of the heart
• trembling or shaking of the hands or feet
• unconsciousness

Minor Side Effects

Some benzonatate side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common or rare:

• Burning sensation in the eyes
• constipation
• dizziness (mild)
• drowsiness (mild)
• headache
• itching
• nausea or vomiting
• skin rash
• stuffy nose

See also:
What are the possible side effects of Diphenhydramine Hcl?

Drowsiness, dizziness, headache, irritability, stomach upset, vision changes (e.g., blurred vision), decreased coordination, constipation, or dry mouth/nose/throat may occur. These effects may decrease as your body adjusts to the medication. If they persist or become bothersome, inform your doctor.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute. Diphenhydramine Hcl can dry up and thicken the mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, be sure to drink plenty of fluids unless otherwise directed by your physician.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as restlessness, confusion), pounding/irregular heartbeat, ringing in the ears, seizure, difficulty urinating.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Diarrhea, laxative effect.

See also:
What are the possible side effects of Phenylephrine Hcl?

Mild upset stomach, trouble sleeping, dizziness, lightheadedness, headache, nervousness, shaking, or fast heartbeat may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This product may reduce blood flow to your hands or feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

If your doctor has directed you to take this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fast/irregular heartbeat, severe/uncontrolled shaking, difficulty urinating.

Tell your doctor right away if any of these rare but very serious side effects occur: seizures, mental/mood changes (e.g., anxiety, panic, confusion, unusual thoughts/behavior).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Benzonatate is a non-narcotic oral antitussive (cough suppressant) drug which works by anesthetizing the tissues of the lungs and pleura responsible for the cough reflex. It is chemically related to other ester anesthetics such as procaine. It has an anesthetic (numbing) action similar to that of benzocaine and "numbs" the stretch sensors in the lungs. It is the stretching of these sensors with breathing that causes the cough. It was approved by the FDA in 1958

Diphenhydramine Hcl HCl is 2-(diphenylmethoxy)-N, N-dimethylethylamine HCl and occurs as a white, crystalline powder and is freely soluble in water and alcohol.

A centrally acting muscle relaxant whose mode of action has not been established. It is used as an adjunct in the symptomatic treatment of musculoskeletal conditions associated with painful muscle spasm. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1206)

Phenylephrine Hcl is a sympathomimetic amine that acts predominantly on α-adrenergic receptors. It is mainly used to treat nasal congestion, but may also be useful in treating hypotension and shock, hypotension during spinal anaesthesia, prolongation of spinal anaesthesia, paroxysmal supraventricular tachycardia, symptomatic relief of external or internal hemorrhoids, and to increase blood pressure as an aid in the diagnosis of heart murmurs.