CHILDRENS SILFEDRINE- pseudoephedrine hydrochloride liquid

Childrens Silfedrine by

Drug Labeling and Warnings

Childrens Silfedrine by is a Otc medication manufactured, distributed, or labeled by Lannett Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose: Nasal decongestant

INDICATIONS & USAGE

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

SPL UNCLASSIFIED SECTION

Manufactured by:

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

10-1031   Rev. 04/18

PRINCIPAL DISPLAY PANEL

118 mL

INGREDIENTS AND APPEARANCE

CHILDRENS SILFEDRINE 
pseudoephedrine hydrochloride liquid

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

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 (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; Type 0: Not a Combination Product	01/05/2001
2	NDC: 54838-104-70	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/05/2001

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/05/2001

Labeler - Lannett Company, Inc. (161630033)