CHILDRENS SILFEDRINE - pseudoephedrine hydrochloride liquid 
Silarx Pharmaceuticals, Inc

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.

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Children's Silfedrine Liquid

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

Purpose: Nasal decongestant

Uses temporarily relieves nasal congestion due to

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

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 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

Manufactured by:

Silarx Pharmaceuticals, Inc
1033 Stoneleigh Ave
Carmel, NY 10512 USA


Container Label 118mL


Container Label 237mL


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 (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)  
glycerin (UNII: PDC6A3C0OX)  
saccharin sodium dihydrate (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:54838-104-40 118 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: 6/2014
Document Id: c7da7339-b0ae-4142-8973-84661ab4ccd2
Set id: 62722653-d91a-4822-b9fa-1d95269d1ec6
Version: 13
Effective Time: 20140625
 
Silarx Pharmaceuticals, Inc