MedPath

Kroger Extra Strength

Extra Strength Antacid Tablets Calcium Carbonate 750 mg

Approved
Approval ID

3f737ce2-961e-4bd0-ae6d-078248cf1c67

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.

Calcium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code30142-207
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
Calcium Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (8)

ADIPIC ACIDInactive
Code: 76A0JE0FKJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 750 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

NDC 30142-207-90

Kroger ®

FOR OUR FAMILY TO YOURS

COMPARE TO the active ingredient in EXTRA STRENGTH TUMS**®**

**See back panel

Sugar Free

EXTRA STRENGTH

Antacid Tablets

Calcium Carbonate USP 750 mg

Orange Cream Flavor

NATURALLY & ARTIFICIALLY FLAVORED

  • FAST RELIEF OF UPSET STOMACH, HEARTBURN AND ACID INDEGESTION
  • GLUTEN FREE

90 CHEWABLE TABLETS

K PARVE

Distributed by:

THE KROGER CO. CINCINNATI, OHIO 45202

QUALITY GUARANTEE

1800-632-6900 www.kroger.com

**TUMS ®is registered trademark of GlaxoSmithKline LLC, Wilmington, DE 19808. GlaxoSmithKline LLC is not affiliated with The Kroger Co. or this product.

Kroger Extra Strength Sugar Free 90 Cheawble Tablets

INDICATIONS & USAGE SECTION

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

Uses

relieves

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/9/2019

Keep out of reach of children.

OTC - ACTIVE INGREDIENT SECTION

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

Active ingredient (per tablet)

Calcium Carbonate USP 750 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/9/2019

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 9 tablets in 24 hours
  • if pregnant do not take more than 6 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

DOSAGE & ADMINISTRATION SECTION

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

Directions

***adults and children 12 years of age and over:**chew 2-4 tablets completely as symptoms occur, or as directed by a doctor. Do not swallow tablets whole.

  • do not take for symptoms that persist for more than 2 weeks except under the advice and supervision of a doctor.

SPL UNCLASSIFIED SECTION

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

Other Information

***each tablet contains:**elemental calcium 300mg

  • Store at room temperature. Keep the container tightly closed

Safety sealed: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/1/2025

Questions or comments?

1-800-632-6900

INACTIVE INGREDIENT SECTION

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

Inactive ingredients

adipic acid, FD&C Yellow No. 6, flavors, magnesium stearate, maltodextrin, sorbitol, starch, sucralose.

Questions or comments?

1-800-632-6900

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Kroger Extra Strength - FDA Drug Approval Details