Bromfed DM

• Morton Grove Pharm., Inc.

• Morton Grove Pharmaceuticals, Inc.

• Muro Pharmaceutical, Inc.

• Victory Pharma, Inc.

• Wockhardt Usa, Llc

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not use brompheniramine, dextromethorphan, and pseudoephedrine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

To make sure this medicine is safe for you, tell your doctor if you have:

• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

• a blockage in your digestive tract (stomach or intestines);

• high blood pressure, heart disease;

• liver or kidney disease;

• glaucoma;

• cough with mucus, or cough caused by emphysema or chronic bronchitis;

• enlarged prostate or urination problems;

• pheochromocytoma (an adrenal gland tumor);

• overactive thyroid; or

• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

FDA pregnancy category C. It is not known whether brompheniramine, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

This medicine can pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• It is used to treat nose stuffiness.
• It is used to ease allergy signs.
• It is used to relieve coughing.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Signs and Symptoms

Central nervous system effects from overdosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted. Toxic doses of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias; signs of CNS depression may occasionally be seen. Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures.

Toxic Doses

Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug. A 2½-year-old child survived the ingestion of 21 mg/kg of dextromethorphan exhibiting only ataxia, drowsiness, and fever, but seizures have been reported in 2 children following the ingestion of 13–17 mg/kg. Another 2½-year-old child survived a dose of 300–900 mg of brompheniramine. The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg.

Treatment

Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances tracheostomy may be necessary prior to lavage. Naloxone hydrochloride 0.005 mg/kg intravenously may be of value in reversing the CNS depression that may occur from an overdose of dextromethorphan. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated.

Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours. Children 2 to under 6 years of age: 2.5 mL (½ teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician.

Do not exceed 6 doses during a 24-hour period.

NDC 60432-837-04

FDA-Approved

Bromfed® DM

Cough Syrup

Each 5 mL (teaspoonful) contains:

Brompheniramine Maleate, USP  2 mg

Pseudoephedrine Hydrochloride, USP  30 mg

Dextromethorphan Hydrobromide, USP  10 mg

Alcohol 0.95% v/v

Rx Only

WOCKHARDT

NET: 4 fl oz (118 mL)

DO NOT USE IF INNER FOIL SEAL PRINTED "SEALED

FOR YOUR PROTECTION" IS BROKEN OR MISSING.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble passing urine.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Shortness of breath.
• Shakiness.
• Seizures.
• Blurred eyesight.