BROTAPP PE LIQUID  - brompheniramine maleate and phenylephrine hydrochloride liquid 
Silarx Pharmaceuticals, Inc

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Brotapp PE Liquid

Drug Facts

Active ingredients (in each 5 mL)                             Purpose

Brompheniramine maleate 1 mg . . . . . . . . . . . . . . . . . . . . . . . Antihistamine
Phenylephrine hydrochloride 2.5 mg . . . . . . . . . . . . . . . . . . . . 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 6 doses in any 24-hour period

Adults and children 12 years and over	4 teaspoonfuls every 4 hours
Children 6 to under 12 years	2 teaspoonfuls every 4 hours
Children under 6 years	DO NOT USE

Other information
Store at 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

†This product is not manufactured or distributed by Wyeth Consumer Healthcare owner of the registered trademark Dimetapp®.

Manufactured by:

Silarx Pharmaceuticals, Inc
19 West Street
Spring Valley, NY 10977
USA

Rev. 3/09

BROTAPP PE LIQUID  brotapp pe liquid   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 54838-143 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 Phenylephrine hydrochloride (Phenylephrine) Phenylephrine hydrochloride 2.5 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 # NDC Package Description Multilevel Packaging 1 54838-143-40 118 mL In 1 BOTTLE, PLASTIC None 2 54838-143-70 237 mL In 1 BOTTLE, PLASTIC None 3 54838-143-80 473 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	12/26/2007

Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 05/2009Silarx Pharmaceuticals, Inc