BROTAPP- brompheniramine maleate and pseudoephedrine hydrochloride liquid

Brotapp by

Drug Labeling and Warnings

Brotapp 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(TSP))

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

PURPOSE

Purpose of Brompheniramine maleate: Antihistamine

Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant

INDICATIONS & USAGE

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 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.
1033 Stoneleigh Ave
Carmel, NY 10512 USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BROTAPP 
brompheniramine maleate and pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54838-125
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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
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: 54838-125-40	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/05/2001
2	NDC: 54838-125-70	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/05/2001
3	NDC: 54838-125-80	473 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)