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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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

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 (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 dihydrate
sodium benzoate
sodium citrate
sorbitol
water

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (Grape Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:54838-104-40	118 mL in 1 BOTTLE, PLASTIC	None
2	NDC: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: 06/2012 Silarx Pharmaceuticals, Inc