Gas Relief by The Kroger Co. Drug Facts

Drug Details [pdf]

GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled
The Kroger Co.

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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Drug Facts

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.

In case of overdose, get medical help or contact a Poison Control Center right away.

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?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of GAS-X®**

Gas Relief

Simethicone 125 mg, Anti-Gas

EXTRA STRENGTH

Fast Relief of:

Pressure
Bloating
Discomfort

SOFTGELS

EASY TO SWALLOW

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

www.kroger.com

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

**Gas-X® is a registered trademark of Novartis Consumer Health, Inc., Summit, NJ 07901. Novartis Consumer Health, Inc. is not affiliated with The Kroger Co. or this product.

GLUTEN FREE

Product Label

Kroger Gas Relief Softgel

GAS RELIEF EXTRA STRENGTH
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-242
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
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 30142-242-30	2 in 1 CARTON	10/15/2013	12/31/2019
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 30142-242-60	4 in 1 CARTON	10/15/2013	12/31/2019
2		15 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	part347	10/15/2013	12/31/2019

Labeler - The Kroger Co. (006999528)

Revised: 12/2018

Document Id: 1c884d6a-bd93-4308-9365-a6ad8c730599

Set id: e43dccfe-a595-4279-9739-bdedbca3379a

Version: 3

Effective Time: 20181218

Trademark Results [Gas Relief]

Mark Image Registration \| Serial	Company Trademark Application Date
GAS RELIEF 85443589 not registered Dead/Abandoned	Traditional Medicinals 2011-10-10