BROTAPP DM COLD AND COUGH  - brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid 
Silarx Pharmaceuticals, Inc

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Brotapp DM Cold & Cough Liquid

Drug Facts

Active ingredients (in each 5 mL)                                         Purpose
Brompheniramine maleate 1 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Antihistamine
Pseudoephedrine hydrochloride 15 mg . . . . . . . . . . . . . . . . . . . . . . . . . .Nasal Decongestant
Dextromethorphan hydrobromide 5 mg . . . . . . . . . . . . . . . . . . . . . . . . . .Cough Suppressant

Uses

Warnings

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions


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
Other information

Inactive ingredients

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.

Questions


container label 118 mL

container label 237 mL


BROTAPP DM COLD AND COUGH 
brompheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide   liquid
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 54838-136
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Brompheniramine maleate (Brompheniramine) Brompheniramine maleate 1 mg  in 5 mL
Pseudoephedrine hydrochloride (Pseudoephedrine) Pseudoephedrine hydrochloride 15 mg  in 5 mL
Dextromethorphan hydrobromide (Dextromethorphan) Dextromethorphan hydrobromide 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid  
FD&C blue no. 1  
FD&C red no. 40  
glycerin  
propylene glycol  
saccharin sodium  
sodium benzoate  
sodium citrate  
sorbitol  
water  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE (grape flavor) Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 54838-136-40 118 mL In 1 BOTTLE, PLASTIC None
2 54838-136-70 237 mL In 1 BOTTLE, PLASTIC None

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: 06/2010 Silarx Pharmaceuticals, Inc