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Ultra Strength Antacid

Kroger Ultra Strength Antacid Tablets Calcium Carbonate 1000mg Peppermint Flavor

Approved
Approval ID

f5d82d1b-2f75-4af4-8337-a5bd28c26fb7

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.

Antacid Tablets

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code30142-993
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
Antacid Tablets
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (6)

DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 1000 mg in 1 1
Code: H0G9379FGK
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Package/Label Principal Display Panel

Kroger ®

COMPARE TO the active ingredient of Tums® Ultra Strength

**See back Panel *FAST RELIEF OF UPSET STOMACH, HEARTBURN, AND ACID INDIGESTION

ULTRA STRENGTH

Antacid

Tablets

Calcium Carbonate USP 1,000 mg

Peppermint Flavor

NATURALLY AND ARTIFICIALLY FLAVORED

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

QUALITY GUARANTEE

1800-632-6900

www.Kroger.com

GLUTEN FREE

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

Package Label 160 Chewable Tablets

Kroger Ultra Strength Peppermint Flavor 160 Chewabl Tablets

Package Label 72 Chewable Tablets

Kroger Ultra Strength Peppermint Flavor 72 Chewabl Tablets

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2025

Uses

relieves

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Active ingredient (per tablet)

Calcium Carbonate USP 1000mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2025

Purpose

Antacid

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2025

Warnings

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

  • do not take more than 7 tablets in 24 hours
  • if pregnant do not take more than 5 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/1/2025

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2025

Directions

***adults and children 12 years of age and over:**chew 2-3 tablets as symptoms occur, or as directed by a doctor

  • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/1/2025

Other information

  • each tablet contains**: elemental calcium 400mg**
  • store at room temperature. Keep the container tightly closed.

INACTIVE INGREDIENT SECTION

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

Inactive ingredients

dextrose, flavors, magnesium stearate, maltodextrin, starch, sucralose.

Questions?

1-800-632-6900

Safety sealed: Do not use if printed seal under cap is torn or missing

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Ultra Strength Antacid - FDA Drug Approval Details