CHILDRENS SILFEDRINE- pseudoephedrine hydrochloride liquid
Lannett Company, 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

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 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

1-844-834-0530

Manufactured by:

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

10-1031 Rev. 04/18

118 mL

CHILDRENS SILFEDRINE
pseudoephedrine hydrochloride liquid

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	15 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54838-104-40	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/05/2001	02/29/2020
2	NDC:54838-104-70	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/05/2001	04/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/05/2001	04/30/2020

Labeler - Lannett Company, Inc. (002277481)

Revised: 4/2018

Document Id: b258710c-7357-42e0-8cdf-35e3e719d2f3

Set id: 62722653-d91a-4822-b9fa-1d95269d1ec6

Version: 16

Effective Time: 20180420

Lannett Company, Inc.