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Name:Brotapp
Manufacturer:Silarx Pharmaceuticals, Inc
Category:Over-the-counter (OTC) Marketed Drugs


Brotapp Liquid

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)

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

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 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, 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 Type HUMAN OTC DRUG Item Code (Source) NDC:54838-125
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
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid  
FD&C blue no. 1  
FD&C red no. 40  
propylene glycol  
saccharin sodium  
sodium benzoate  
sodium citrate  
sorbitol  
water  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE (grape flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54838-125-40 118 mL in 1 BOTTLE, PLASTIC None
2 NDC:54838-125-70 237 mL in 1 BOTTLE, PLASTIC None
3 NDC:54838-125-80 473 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: 06/2011 Silarx Pharmaceuticals, Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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