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
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.
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.
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.
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
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 DM brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide syrup | ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
|
Labeler — Morton Grove Pharmaceuticals, Inc. (801897505) |
Registrant — Morton Grove Pharmaceuticals, Inc. (801897505) |
Revised: 01/2021 Morton Grove Pharmaceuticals, Inc.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.