Bromfed DM (Page 2 of 2)

ADVERSE REACTIONS

The most frequent adverse reactions to Bromfed® DM Cough Syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:

Dermatologic: Urticaria, drug rash, photosensitivity, pruritus.

Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias, palpitation.

CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria.

G.U. System: Urinary frequency, difficult urination.

G.I. System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.

Respiratory System: Tightness of chest and wheezing, shortness of breath.

Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

OVERDOSAGE

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

Bromfed® DM Cough Syrup is a clear, light pink-colored, butterscotch-flavored syrup containing in each 5 mL (1 teaspoonful) brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following sizes:

4 fl oz (118 mL) NDC 60432-837-04

1 Pint (473 mL) NDC 60432-837-16

RECOMMENDED STORAGE

Store at 20 ° to 25 °C (68 ° to 77 °F) [See USP Controlled Room Temperature].

KEEP TIGHTLY CLOSED

Dispense in a tight, light-resistant container as defined in the USP.

Rx Only

Product No.: 8837

BROMFED® is a registered trademark of Wockhardt.

bromfed-04

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

A50-8837-16

REV. 08-15

PRINCIPAL DISPLAY PANEL Bottle Label

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.

bromfed-05
(click image for full-size original)
BROMFED DM
brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-837
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE 2 mg in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
PROPYLENE GLYCOL
SODIUM BENZOATE
ANHYDROUS CITRIC ACID
ALCOHOL
METHYLPARABEN
FD&C RED NO. 40
SUCROSE
TRISODIUM CITRATE DIHYDRATE
Product Characteristics
Color PINK (Light Pink) Score
Shape Size
Flavor BUTTERSCOTCH Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60432-837-04 118 mL in 1 BOTTLE, PLASTIC None
2 NDC:60432-837-16 473 mL in 1 BOTTLE, PLASTIC None
3 NDC:60432-837-15 15 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088811 06/15/2010
Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)
Registrant — Morton Grove Pharmaceuticals, Inc. (801897505)

Revised: 01/2021 Morton Grove Pharmaceuticals, Inc.

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