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

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

• 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 teaspoonfuls every 6 hours
Children 6 to under 12 years	2 teaspoonfuls 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

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: 12/2010Silarx Pharmaceuticals, Inc