Your browser does not support JavaScript! CHILDRENS SILFEDRINE (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC]
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CHILDRENS SILFEDRINE (pseudoephedrine hydrochloride) liquid
[Silarx Pharmaceuticals, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

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

When using this product do not use more than directed

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or accompanied by fever

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

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

Children 6 to 11 years of age
2 teaspoonfuls (TSP)
Children 4 to 5 years of age
1 teaspoonful(TSP)
Children under 4 years of ageDO 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

Manufactured by:

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


Container Label 118mL


Container Label 237mL


CHILDRENS SILFEDRINE 
pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54838-104
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pseudoephedrine hydrochloride (Pseudoephedrine) Pseudoephedrine hydrochloride15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
FD&C blue no. 1 
FD&C red no. 40 
glycerin 
saccharin sodium dihydrate 
sodium benzoate 
sodium citrate 
sorbitol 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54838-104-40118 mL in 1 BOTTLE, PLASTIC
2NDC:54838-104-70237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/05/2001
Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 12/2012
Document Id: 7ecedac4-e711-4692-9998-c969020bfd80
Set id: 62722653-d91a-4822-b9fa-1d95269d1ec6
Version: 10
Effective Time: 20121227
 
Silarx Pharmaceuticals, Inc

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