SHOPRITE INFANTS SIMETHICONE- simethicone emulsion

ShopRite Infants Simethicone by

Drug Labeling and Warnings

ShopRite Infants Simethicone by is a Otc medication manufactured, distributed, or labeled by Wakefern Food Corporation. 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.

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 over 2	over 24	0.6 mL

Other information

store at room temperature (59°-86°F)

Inactive ingredients

citric acid, flavor, hypromellose, maltitol, methylcellulose, mono- and di- glycerides, polyethylene glycol, polyethylene glycol stearate, polysorbate 65, purified water, sodium benzoate, sodium citrate, sorbic acid, xanthan gum

Questions or comments?

1-800-SHOPRITE

Principal Display Panel

Compare to: Active Ingredient in Infants’ Mylicon® Drops

Infants’

SIMETHICONE DROPS

SIMETHICONE 20 mg

ANTI-GAS

Gas Relief

Non-Staining

No Alcohol

No Saccharin

No Artificial Flavor

No Artificial Colors

Dosage Dropper Enclosed

1 FL OZ (30mL)

INGREDIENTS AND APPEARANCE

SHOPRITE INFANTS SIMETHICONE 
simethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41190-882
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MALTITOL (UNII: D65DG142WK)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBIC ACID (UNII: X045WJ989B)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 65 (UNII: 14BGY2Y3MJ)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41190-882-10	1 in 1 CARTON	06/16/2013
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	06/16/2013

Labeler - Wakefern Food Corporation (069722418)