MedPath

Kroger Extra Strength

Kroger Extra Strength Antacid Calcium Drug Facts

Approved
Approval ID

fa191237-d230-4528-8dff-50e8d5c65b6d

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 Code30142-200
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 (9)

ADIPIC ACIDInactive
Code: 76A0JE0FKJ
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
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: 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 #30142-200-96

Kroger**®**

COMPARE TO active ingredient in EXTRA STRENGTH TUMS® see back panel

OUR PHARMACISTS RECOMMEND

EXTRA STRENGTH

Antacid Tablets

Calcium Carbonate 750 mg

FAST RELIEF:

Upset Stomach, Heartburn & Acid Indigestion

Assorted Berry

NATURALLY & ARTIFICIALLY FLAVORED

96 CHEWABLE TABLETS

GLUTEN- FREE

K PAREVE

QUALITY GUARANTEED-

DISTRIBUTED BY:

THE KROGER CO.

CINCINNATI,

OHIO 45202

800-632-6900 www.kroger.com

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

Kroger Assorted Berries 96 Chewable Tablets

INDICATIONS & USAGE SECTION

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

Uses

relieves

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

OTC - ACTIVE INGREDIENT SECTION

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

Active ingredient (per tablet)

Calcium Carbonate USP 750mg

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 10 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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 2-4 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 unless advised by 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

INACTIVE INGREDIENT SECTION

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

Inactive ingredients

adipic acid, dextrose, FD&C blue No. 1, FD&C Red No. 40, flavors, magnesium stearate, maltodextrin, starch, sucralose.

Questions?

1-800-632-6900

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Kroger Extra Strength - FDA Drug Approval Details