SHOPRITE INFANTS SIMETHICONE- simethicone emulsion
Wakefern Food Corporation

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.

----------

ShopRite Infants’ Simethicone Drops 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.

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)

SHOPRITE INFANTS SIMETHICONE
simethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41190-882
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MALTITOL (UNII: D65DG142WK)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41190-882-10	1 in 1 CARTON	06/16/2013	02/25/2019
1		30 mL in 1 BOTTLE; 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	06/16/2013	02/25/2019

Labeler - Wakefern Food Corporation (069722418)

Revised: 10/2021

Document Id: 87e32e54-e71e-4fd3-971e-f21f3b4eab44

Set id: a16907fc-d3cb-410c-a8ee-c47b0d2cd827

Version: 3

Effective Time: 20211006

Wakefern Food Corporation