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|Tussal-ER Sustained-Release Tablets

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Tussal-ER Sustained-Release Tablets

Generic Name: Dexbrompheniramine/Dextromethorphan/Phenylephrine Sustained-Release Tablets (dex-brome-fen-IR-a-meen/dex-troe-meth-OR-fan/fen-ill-EF-rin)
Brand Name: Tussal-ER and Y-Cof DM

Tussal-ER Sustained-Release Tablets is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Tussal-ER Sustained-Release Tablets is a decongestant, antihistamine, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing while the cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Tussal-ER Sustained-Release Tablets if:

you are allergic to any ingredient in Tussal-ER Sustained-Release Tablets
you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
you are unable to urinate or are having an asthma attack
you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tussal-ER Sustained-Release Tablets:

Some medical conditions may interact with Tussal-ER Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a fast, slow, or irregular heartbeat
if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or an overactive thyroid
if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Tussal-ER Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Tussal-ER Sustained-Release Tablets may be increased
Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Tussal-ER Sustained-Release Tablets
Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Tussal-ER Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tussal-ER Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tussal-ER Sustained-Release Tablets:

Use Tussal-ER Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Tussal-ER Sustained-Release Tablets may be taken with or without food.
Swallow Tussal-ER Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing.
If you miss a dose of Tussal-ER Sustained-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 Tussal-ER Sustained-Release Tablets.

Important safety information:

Tussal-ER Sustained-Release Tablets may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tussal-ER Sustained-Release Tablets. Using Tussal-ER Sustained-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Do not take diet or appetite control medicines while you are taking Tussal-ER Sustained-Release Tablets without checking with your doctor.
Tussal-ER Sustained-Release Tablets contains dexbrompheniramine, dextromethorphan, and phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains dexbrompheniramine, dextromethorphan, or phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.
Do NOT exceed the recommended dose or take Tussal-ER Sustained-Release Tablets for longer than prescribed without checking with your doctor.
If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
Tussal-ER Sustained-Release Tablets may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Tussal-ER Sustained-Release Tablets. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
If you are scheduled for allergy skin testing, do not take Tussal-ER Sustained-Release Tablets for several days before the test because it may decrease your response to the skin tests.
Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Tussal-ER Sustained-Release Tablets.
Use Tussal-ER Sustained-Release Tablets with caution in the ELDERLY because they may be more sensitive to its effects.
Caution is advised when using Tussal-ER Sustained-Release Tablets in CHILDREN because they may be more sensitive to its effects.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Tussal-ER Sustained-Release Tablets, discuss with your doctor the benefits and risks of using Tussal-ER Sustained-Release Tablets during pregnancy. It is unknown if Tussal-ER Sustained-Release Tablets is excreted in breast milk. Do not breast-feed while taking Tussal-ER Sustained-Release Tablets.

Possible side effects of Tussal-ER Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Tussal-ER Sustained-Release Tablets:

Store Tussal-ER Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tussal-ER Sustained-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Tussal-ER Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Tussal-ER Sustained-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Tussal-ER Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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