PEDIACARE INFANTS GAS RELIEF DYE FREE- simethicone liquid
Prestige Brands Holdings, 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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PediaCare Infants Gas Relief Drops Dye Free

Drug Facts

Active ingredient

(in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

Relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Warnings

When using this product

do not exceed 12 doses per day

Keep this and all drugs out of the reach of children.

In case of overdose get medical help or contact a poison control center right away.

Directions

shake well before using
all dosages may be repeated as needed, after meals and at bedtime
fill enclosed dropper to recommended dosage level
dispense liquid slowly into baby’s mouth, toward the inner cheek
may mix with 1 oz. of cool water, infant formula or other suitable liquids
clean dropper after each use and replace original cap

age (yr)	weight (lb)	dose
infants under 2	under 24	0.3 mL
children 2 and over	over 24	0.6 mL

Other information

store at room temperature (59°F - 86°F)

Inactive ingredients

benzoic acid, magnesium aluminum silicate, natural flavor, purified water, sorbitol, xanthan gum.

Questions or comments?

call 1-888-474-3099

PRINCIPAL DISPLAY PANEL

New PediaCare® Infants
Gas Relief Drops
Dye Free/Non Staining
1 FL OZ (30 mL)

PEDIACARE INFANTS GAS RELIEF DYE FREE
simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-353
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	0.37 mg in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	6.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-353-01	1 in 1 CARTON	10/12/2010	08/31/2017
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part332	10/12/2010	08/31/2017

Labeler - Prestige Brands Holdings, Inc. (159655021)

Revised: 10/2010

Document Id: 7981cea1-3c0a-4e70-8ae2-001805f64fd5

Set id: 467af525-ea12-4261-a164-b262f1a017b2

Version: 3

Effective Time: 20101018

Prestige Brands Holdings, Inc.