GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled

Gas Relief by

Drug Labeling and Warnings

Gas Relief by is a Otc medication manufactured, distributed, or labeled by EQUATE (Wal-Mart Stores, Inc.). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

• for the relief of pressure, bloating, and fullness commonly referred to as gas

Warnings

If pregnant or breast-feeding,

ask a health professional before use.

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 unless directed by a doctor

Other information

• store at controlled room temperature 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, medium-chain triglycerides*, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

*may contain this ingredient

Questions or comments?

Call 1-888-287-1915

Principal Display Panel

Compare to Gas-X® Active Ingredient†

Extra Strength

Gas Relief

Simethicone 125 mg

Anti-Gas

Fast Relief of:

Pressure   Bloating   Discomfort

SOFTGELS

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by: Wal-Mart Stores, Inc.

Bentonville, AR 72716

†This product is not manufactured or distributed by Novartis, owner of the registered trademark Gas-X®

Product Label

Equate Extra Strength Gas Relief Softgels

INGREDIENTS AND APPEARANCE

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-242
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	PO;S1;SCU
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-242-20	2 in 1 CARTON	10/15/2013	12/31/2020
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 49035-242-72	4 in 1 CARTON	10/15/2013	12/31/2020
2		18 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 49035-242-14	2 in 1 PACKAGE	10/15/2013	12/31/2020
3		72 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 49035-242-15	150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/15/2013	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	10/15/2013	12/31/2020

Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)