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Kroger Extra Strength

Kroger Extra Strength Gas Relief 30 Softgels Drug Facts

Approved
Approval ID

67ddce93-4d68-4280-bf8b-337b91ab8c8f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

KROGER COMPANY

DUNS: 006999528

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Simethicone Antigas

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code30142-330
Application NumberM002
Product Classification
M
Marketing Category
C200263
G
Generic Name
Simethicone Antigas
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (9)

D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIMETHICONE, UNSPECIFIEDActive
Quantity: 125 mg in 1 1
Code: 92RU3N3Y1O
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

Principal Display Panel

NDC 30142-330-30

*COMPARE TO the active ingredient GAS-X® EXTRA STRENGTH SOFTGELS See back panel

Extra Strength

Gas Relief

Simethicone/125 mg

ANTI-GAS

FAST RELIEF OF:

  • Gas
  • Pressure
  • Bloating
  • Discomfort

Small, Easy to Swallow

30 SOFTGELS

**IMPORTANT:**KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING.

This product offers, effective relief of pressure and bloating that antacid can’t provide. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating or discomfort referred to as gas.

*Gas-X® Softgels is registered trademark of GSK Consumer Healthcare, Inc. Warren, NJ 07059. GSK Consumer Healthcare, Inc. is not affiliated with The Kroger Co. or this product.

DO NOT USE IF ANY INDIVIDUAL BLISTERS UNIT IS BROKEN OR OPEN.

DISTRIBUTED BY:

THE KROGER CO.

CINCINNATI, OHIO 45202

QUALITY GUARANTEE

800-632-6900

www.kroger.com

Kroger Extra Strength Simethicone Softgels

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/31/2020

Uses

for relief of:

  • pressure, bloating and fullness commonly referred to as gas

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/31/2020

Active ingredient (in each softgel)

Simethicone 125 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/31/2020

Purpose

Antigas

WARNINGS SECTION

LOINC: 34071-1Updated: 3/31/2020

Warnings

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/31/2020

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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 3/31/2020

Other information

  • store at room temperature
  • protect from light, heat and moisture.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2025

Inactive ingredients

D&C Yellow No. 10, edible printing ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide.

Questions or comments?

1-800-632-6900

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Kroger Extra Strength - FDA Drug Approval Details