CHILDRENS SILFEDRINE  - pseudoephedrine hydrochloride liquid 
Silarx Pharmaceuticals, Inc

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Children's Silfedrine Liquid

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

Purpose: Nasal decongestant

Uses temporarily relieves nasal congestion due to

• common cold
  
• hay fever
  
• other upper respiratory allergies
  
• temporarily relieves sinus congestion and pressure
  
• promotes nasal and/or sinus drainage

Warnings

DO NOT USE IN CHILDREN UNDER 4 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 diseases
  
• high blood pressure
  
• thyroid disease
  
• diabetes
  
• trouble urinating due to an enlarged prostate gland
  

When using this product do not use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
  
• symptoms do not improve within 7 days or 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 (1800-222-1222).

Directions

• Repeat dose every 4 to 6 hours if needed.
  
• Do not exceed 4 doses in 24 hours.

Children 6 to 11 years of age	2 teaspoonfuls
Children 4 to 5 years of age	1 teaspoonful
Children under 4 years of age	DO NOT USE

Other information

store at room temperature

Inactive ingredients

citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, grape flavor, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution.

Questions

888-974-5279

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Sudafed® Nasal Decongestant Liquid.

Manufactured by:

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

CHILDRENS SILFEDRINE  pseudoephedrine hydrochloride   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 54838-104 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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   glycerin   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 54838-104-40 118 mL In 1 BOTTLE, PLASTIC None 2 54838-104-70 237 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	01/05/2001

Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 12/2010Silarx Pharmaceuticals, Inc