BABIES R US GAS RELIEF INFANTS- simethicone emulsion
Toys"R"Us, 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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Toys "R" Us, Inc. Infants' Gas Relief 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 out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

•: shake well before using
•: all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day.
•: fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek
•: dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
•: clean dropper well after each use – recap bottle with original cap

Age (yr)	Weight (lb)	Dose
infants under 2	under 24	0.3 mL
children over 2	over 24	0.6 mL

Other information

•: store at 20-25°C (68-77°F)
•: do not use if printed bottle wrap is broken or missing

Inactive ingredients

anhydrous citric acid, flavor, hypromellose, maltitol solution, purified water, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum

Questions?

1-800-719-9260

Principal Display Panel

Infants’ Gas Relief

Simethicone Drops 20 mg – Anti-Gas

Dye Free

No Alcohol

No Saccharin

No Artificial Flavor

No Artificial Colors

Non Staining Formula

Compare to the active ingredient of Infants’ Mylicon® Drops Non-Staining

1 fl oz (30 mL)

BABIES R US GAS RELIEF INFANTS
simethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51334-882
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg in 0.3 mL

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HYPROMELLOSES (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBIC ACID (UNII: X045WJ989B)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (white to off white, opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51334-882-10	1 in 1 CARTON	02/16/2011	08/22/2017
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	02/16/2011	08/22/2017

Labeler - Toys"R"Us, Inc. (006985808)

Revised: 11/2017

Document Id: 52bd4c2d-df1c-4c50-950b-a5a728b05b36

Set id: cb8770ca-73bb-438a-88c5-65e0c326bfa2

Version: 3

Effective Time: 20171125

Toys"R"Us, Inc.