MedPath

Kroger Extra Strength

Kroger Extra Strength Gas Relief Simethicone

Approved
Approval ID

6aa691e4-3179-4cf7-855a-e44f16904c1c

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 Code30142-481
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)

SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28
Classification: IACT
DIMETHICONE, UNSPECIFIEDActive
Quantity: 125 mg in 1 1
Code: 92RU3N3Y1O
Classification: ACTIB
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Principal Display Panel

NDC 30142-481-48

*Compare to the active ingredient in GAS-X ®Extra Strength

Extra Strength

Gas Relief

Simethicone//Anti-gas

For Fast Relief of Pressure,

Bloating & Gas Distress

Cherry Creme Flavor

Naturally and Artificially Flavored

48 Chewable Tablets

Distributed by:

*This product is not manufactured or distributed by GSK Consumer Healthcare, Inc., the distributor of Gas-X ®Extra strength.

**IMPORTANT:**Keep this carton for future reference on full labeling.

Kroger Extra Strength Gas Relief Simethicone

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/1/2020

Uses

for the relief of

  • pressure, bloating and fullness commonly referred to as gas

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 4/1/2020

Other information

***each tablets contains:**calcium 45 mg

  • store at room temperature
  • protect from excessive heat and moisture

TAMPER EVIDENT: DO NOT USE IF ANY INDVIDUAL BLISTER IS BROKEN OR OPEN

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/1/2020

Inactive ingredients

D&C Red No. 30, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sucralose, tribasic calcium phosphate.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/1/2020

Active ingredient (in each tablet)

Simethicone 125 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/1/2020

Purpose

Anti-gas

WARNINGS SECTION

LOINC: 34071-1Updated: 4/1/2020

Warning

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/1/2020

Directions

*adults: chew 1 to 2 tablets as needed after meals and at bedtime. Do not swallow tablets whole.

  • do not exceed 4 tablets in a 24 hours except under the advice and supervision of a physician.

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Kroger Extra Strength - FDA Drug Approval Details