INFANTS GAS RELIEF- simethicone emulsion

Infants Gas Relief by

Drug Labeling and Warnings

Infants Gas Relief by is a Otc medication manufactured, distributed, or labeled by Shopko Stores Operating Co., LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Compare to Infants’ Mylicon® Drops active ingredient

Infants’

Gas Relief Drops

Simethicone 20 mg/Anti-gas

Safe for Every Feeding

Dye-Free

Non-Staining

No Artificial Colors

No Artificial Flavor

No Alcohol

No Saccharin

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

INFANTS GAS RELIEF 
simethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37012-882
Route of Administration	ORAL

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37012-882-10	1 in 1 CARTON	11/27/2013
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	11/27/2013

Labeler - Shopko Stores Operating Co., LLC (023252638)