BROTAPP DM COLD AND COUGH
-
brompheniramine maleate,
pseudoephedrine hydrochloride and
dextromethorphan hydrobromide liquid
Silarx Pharmaceuticals, Inc
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
Active Ingredient: Brompheniramine maleate 1 mg (in each 5 mL)
Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL)
Active Ingredient: Dextromethorphan hydrobromide 5 mg (in each 5 mL)
Purpose of Brompheniramine maleate: Antihistamine
Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant
Purpose of Dextromethorphan hydrobromide: Cough Suppressant
Uses
Do not use in children under 6 years of age
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
When using this product
Adults and children 12 years and over | 4 teaspoonfuls every 6 hours |
Children 6 to under 12 years | 2 teaspoonfuls every 6 hours |
Children under 6 years | DO NOT USE |
citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, grape flavor, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, water.
BROTAPP DM COLD AND COUGH
brompheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid |
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
||||||||||||||||||||||||
|
Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part341 | 04/05/2001 |
Labeler - Silarx Pharmaceuticals, Inc (161630033) |
Revised: 06/2011 Silarx Pharmaceuticals, Inc