MedPath

Kroger Extra Strength

Kroger Extra Strength 100 Chewable Tablets Original Flavor

Approved
Approval ID

175d9f0f-266a-4dc2-865f-d1ebd4ddac51

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

THE KROGER CO.,

DUNS: 006999528

Products 1

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

aluminum hydroxide and magnesium carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code30142-610
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
aluminum hydroxide and magnesium carbonate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (8)

ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ALUMINUM HYDROXIDEActive
Quantity: 160 mg in 1 1
Code: 5QB0T2IUN0
Classification: ACTIB
MAGNESIUM CARBONATEActive
Quantity: 105 mg in 1 1
Code: 0E53J927NA
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/29/2024

Principal Display Panel

Kroger**®**

NDC 30142-610-00

COMPARE TO the active ingredients GAVISCON®EXTRA STRENGTH ANTACID

*See back panel

Antacid Tablets

EXTRA STRENGTH

Aluminum Hydroxide, 160 mg

Magnesium Carbonate, 105 mg

Fast Acting Heartburn Relief, Helps Keep Acid Down for Hours

  • OUR PHARMACISTS RECOMMEND

100 CHEWABLE TABLETS

Original Flavor

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

QUALITY GUARANTEE

800-632-6900www.kroger.com

GLUTEN FREE

DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

*GAVISCON ®IS A REGISTERED TRADEMARK OF GLAXOSMITHKLINE LLC, WILMINGTON, DE 19808. GLAXOSMITHKLINE LLC IS NOT AFFLIATED WITH THE KROGER CO. OR THIS PRODUCT.

Kroger Antacid 100 Chewable Tablets

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/12/2019

Uses

relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/12/2019

Inactive ingredients

alginic acid, calcium stearate, compressible sugar, flavor, sodium bicarbonate, starch (corn), sucrose.

Questions or comments?

1-800-632-6900

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/12/2019

Active ingredients (in each tablet)

Aluminum hydroxide 160 mg

Magnesium carbonate 105 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/12/2019

Purpose

Antacid

Antacid

WARNINGS SECTION

LOINC: 34071-1Updated: 7/29/2024

Warnings

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug. Antacids may interact with certain prescription drugs
  • If you are on a sodium-restricted diet

When using this product

  • do not take more than 16 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/12/2019

Directions

  • chew 2 to 4 tablets four times a day or as directed by a doctor
  • take after meals and at bedtime or as needed
  • for best results follow by a half glass of water or other liquid
  • DO NOT SWALLOW TABLETS WHOLE

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/12/2019

Other information

  • each tablet contains:magnesium 31 mg, sodium 19 mg
  • Store at room temperature.

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Kroger Extra Strength - FDA Drug Approval Details