BROTAPP DM COLD AND COUGH- brompheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid

Brotapp DM Cold and Cough by

Drug Labeling and Warnings

Brotapp DM Cold and Cough by is a Otc medication manufactured, distributed, or labeled by Lannett Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Brompheniramine maleate 1 mg (in each 5 mL (teaspoon)(TSP))

Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL (teaspoon)(TSP))

Active Ingredient: Dextromethorphan hydrobromide 5 mg (in each 5 mL (teaspoon)(TSP))

PURPOSE

Purpose of Brompheniramine maleate: Antihistamine

Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant

Purpose of Dextromethorphan hydrobromide: Cough Suppressant

INDICATIONS & USAGE

Uses

• temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis
  
• temporarily relieves symptoms due to hay fever (allergic rhinitis):
  
• • runny nose
    
  • sneezing
    
  • itchy, watery eyes
    
  • itching of the nose or throat
    
  • temporarily restores freer breathing through the nose
    

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

• heart disease
  
• high blood pressure
  
• thyroid disease
  
• diabetes
  
• glaucoma
  
• trouble urinating due to an enlarged prostate gland
  
• cough that occurs with too much phlegm (mucus)
  
• breathing problem or persistent or chronic cough that lasts or as occurs with smoking, asthma, emphysema, or chronic bronchitis

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

When using this product

• do not use more than directed
  
• marked drowsiness may occur
  
• avoid alcoholic beverages
  
• alcohol, sedatives, and tranquilizers may increase drowsines
•  be careful when driving a motor vehicle or operating machinery
  
• excitability may occur, especially in children

Stop use and ask a doctor if

• you get nervous, dizzy, or sleepless
  
• symptoms do not improve within 7 days or are accompanied by fever
  
• cough lasts morethan 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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

• do not take more than 4 doses in any 24-hour period

• Adults and children 12 years and over: 4 teaspoons (TSP) every 6 hours
• Children 6 to under 12 years: 2 teaspoons (TSP) every 6 hours
• Children under 6 years: DO NOT USE

Other information
Store at room temperature 20°-25°C (68°-77°F).

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

888-974-5279

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BROTAPP DM COLD AND COUGH 
brompheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54838-136
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	1 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	15 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (grape flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54838-136-40	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/05/2001
2	NDC: 54838-136-70	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/05/2001

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/05/2001

Labeler - Lannett Company, Inc. (161630033)