Understanding and controlling your respiratory allergies

Children's Silfedrine

Generic Name: pseudoephedrine hydrochloride
Dosage Form: oral liquid

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.

Children's Silfedrine Liquid

Drug Facts

Active ingredient (in each 5 mL)                         Purpose

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Pseudoephedrine hydrochloride 15 mg .............. 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 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 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 the reach of children. In case of overdose, get medical help or contact a poison control center right away.

Directions

  • Take at every 6 hours, if needed
  • Do not exceed 4 doses in 24 hours.

Adults and children 12 years of age and over
4 teaspoonfuls
Children 6 to under 12 years of age
2 teaspoonfuls
Children under 6 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

Rev. 05/09




CHILDRENS SILFEDRINE 
pseudoephedrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:54838-104-40 118 mL in 1 BOTTLE, PLASTIC
2 NDC:54838-104-70 237 mL in 1 BOTTLE, PLASTIC
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: 06/2010
 
Silarx Pharmaceuticals, Inc



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