SHOPRITE GAS RELIEF- simethicone capsule, liquid filled
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.

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ShopRite Gas Relief Drug Facts

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Use

for the relief of

•: pressure, bloating and fullness, commonly referred to as gas

Warnings

Keep out of reach of children

Directions

•: adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
•: do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

•: store at 20-25°C (68-77°F)
•: protect from light, heat and moisture

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-800-SHOPRITE

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Compare to: Active Ingredient in Gas-X® Extra Strength Softgels

EXTRA STRENGTH

GAS RELIEF

ANTI-GAS

SIMETHICONE 125 mg

Relieves Gas Fast

Relieves Pressure, Bloating & Discomfort

Easy to Swallow Softgel

actual size

30 SOFTGELS

SHOPRITE GAS RELIEF
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41190-428
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	L428
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41190-428-65	3 in 1 CARTON	06/20/2013	08/31/2019
1		10 in 1 BLISTER PACK; 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	06/20/2013	08/31/2019

Labeler - Wakefern Food Corporation (069722418)

Revised: 12/2020

Document Id: 18280cab-6901-4dfb-b728-07ef92d4ef2f

Set id: 4e9a7c8d-2c0b-48cd-883e-f5560f0e70ad

Version: 3

Effective Time: 20201201

Wakefern Food Corporation