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|Bromfed Sustained-Release Capsules

Bromfed Sustained-Release Capsules

Bromfed Sustained-Release Capsules is used for:

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

Bromfed Sustained-Release Capsules is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure.

Do NOT use Bromfed Sustained-Release Capsules if:

• you are allergic to any ingredient in Bromfed Sustained-Release Capsules
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
• you take sodium oxybate (GHB) or if 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 Bromfed Sustained-Release Capsules:

Some medical conditions may interact with Bromfed Sustained-Release Capsules. 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 asthma; lung problems (eg, emphysema); 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

Some MEDICINES MAY INTERACT with Bromfed Sustained-Release Capsules. 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 Bromfed Sustained-Release Capsules 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 Bromfed Sustained-Release Capsules
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Bromfed Sustained-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bromfed Sustained-Release Capsules 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 Bromfed Sustained-Release Capsules:

Use Bromfed Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

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

Important safety information:

• Bromfed Sustained-Release Capsules 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 Bromfed Sustained-Release Capsules. Using Bromfed Sustained-Release Capsules 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 Bromfed Sustained-Release Capsules without checking with your doctor.
• Bromfed Sustained-Release Capsules contains brompheniramine and phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains brompheniramine or phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.
• Do NOT exceed the recommended dose or take Bromfed Sustained-Release Capsules 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.
• Bromfed Sustained-Release Capsules may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Bromfed Sustained-Release Capsules. 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 Bromfed Sustained-Release Capsules 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 Bromfed Sustained-Release Capsules.
• Use Bromfed Sustained-Release Capsules with caution in the ELDERLY because they may be more sensitive to its effects.
• Caution is advised when using Bromfed Sustained-Release Capsules in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Bromfed Sustained-Release Capsules, discuss with your doctor the benefits and risks of using Bromfed Sustained-Release Capsules during pregnancy. It is unknown if Bromfed Sustained-Release Capsules is excreted in breast milk. Do not breast-feed while taking Bromfed Sustained-Release Capsules.

Possible side effects of Bromfed Sustained-Release Capsules:

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.

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.

Store Bromfed Sustained-Release Capsules 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 Bromfed Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Bromfed Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Bromfed Sustained-Release Capsules 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 Bromfed Sustained-Release Capsules. 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.