SHOPRITE GAS RELIEF- 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’ Gas Relief 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.

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-SHOPRITE

Principal Display Panel

Compare to: Active Ingredient in Infants’ Mylicon® Drops

Infants’

GAS RELIEF DROPS

SIMETHICONE 20 mg

ANTI-GAS

Non-Staining

Dye Free

Gently Breaks Down Baby’s Gas Bubbles

Safe Enough to Use at Every Feeding**

**Use as Directed

1 FL OZ (30 mL)

SHOPRITE GAS RELIEF
simethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41190-703
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)
XANTHAN GUM (UNII: TTV12P4NEE)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41190-703-10	1 in 1 CARTON	07/08/2014	02/25/2019
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	07/08/2014	02/25/2019

Labeler - Wakefern Food Corporation (069722418)

Revised: 3/2019

Document Id: ce893af0-a12f-4067-bd1e-f366e356cdbb

Set id: 37eacc4d-f3d9-4fb0-ac5d-b55e2e5adf0d

Version: 2

Effective Time: 20190314

Wakefern Food Corporation