Bromfed Dm Recall
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Questions & Answers
Side Effects & Adverse Reactions
Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.
Antihistamines may diminish mental alertness. In the young child, they may produce excitation.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
There is currently no drug history available for this drug.
Bromfed® DM Cough Syrup is a clear, light pink syrup with a butterscotch flavor.
Each 5 mL (1 teaspoonful) contains:
Brompheniramine Maleate, USP . . . . . . . . 2 mg
Pseudoephedrine Hydrochloride, USP . . . . . 30 mg
Dextromethorphan Hydrobromide, USP . . . 10 mg
Alcohol 0.95% v/v
In a palatable, aromatic vehicle.
Inactive Ingredients: artificial butterscotch flavor, citric acid anhydrous, dehydrated alcohol, FD&C Red No. 40, glycerin, liquid sugar, methylparaben, propylene glycol, purified water and sodium benzoate. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0.
C16H19BrN2•C4H4O4 M.W. 435.31
Brompheniramine Maleate, USP
C10H15NO•HCl M.W. 201.69
Pseudoephedrine Hydrochloride, USP
C18H25NO•HBr•H2O M.W. 370.32
Dextromethorphan Hydrobromide, USP
Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.