BROTAPP - brompheniramine maleate and pseudoephedrine hydrochloride 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.

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Brotapp Liquid

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

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

Purpose of Brompheniramine maleate: Antihistamine

Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant

Uses

  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis
  • temporarily relieves these 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 a child 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
  • breathing problem such as 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
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • 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

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 (TSP) every 6 hours
Children 6 to under 12 years
2 teaspoonfuls (TSP) every 6 hours
Children under 6 yearsDO 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, grape flavor, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, water.

Questions

888-974-5279

Manufactured by:
Silarx Pharmaceuticals, Inc.
19 West Street
Spring Valley, NY 10977 USA


118 mL Container Label


BROTAPP 
brompheniramine maleate and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54838-125
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Brompheniramine maleate (Brompheniramine) Brompheniramine maleate1 mg  in 5 mL
Pseudoephedrine hydrochloride (Pseudoephedrine) Pseudoephedrine hydrochloride15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
FD&C blue no. 1 
FD&C red no. 40 
propylene glycol 
saccharin sodium dihydrate 
sodium benzoate 
sodium citrate 
sorbitol 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (grape flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54838-125-40118 mL in 1 BOTTLE, PLASTIC
2NDC:54838-125-70237 mL in 1 BOTTLE, PLASTIC
3NDC:54838-125-80473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/05/2001
Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 6/2013
Document Id: f79b647f-c795-4c33-bf7c-3623eb34094e
Set id: 5a6dbbda-a393-4cbe-b876-1314865a913e
Version: 13
Effective Time: 20130621
 
Silarx Pharmaceuticals, Inc