MedPath

Kroger Ultra Strength

Kroger Ultra Strength Antacid Calcium Carbonate Drug Facts

Approved
Approval ID

b7db77a7-0580-455b-a2ef-a68584f03981

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 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 Code30142-300
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
Calcium Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (9)

ADIPIC ACIDInactive
Code: 76A0JE0FKJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
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: 8/13/2025

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 1000 mg

Assorted Berry Flavors

GLUTEN FREE

Our Pharmacists Recommend

K PAREVE

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

QUALITY GUARANTEE

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.

Package Label 160 Chewable Tablets

Kroger Ultra Strength Assorted Berry Antacid 160 Chewable Tablets

Generic Section

Package Label for 72 Chewable Tablets

Kroger Ultra Strength Assorted Berry Antacid 72 Chewable Tablets

Generic Section

Package Label for 160 Twin Pack Chewable Tablets

Kroger Ultra Strength Assorted Berry Antacid 160 Twin Pack 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 - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 7/9/2019

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

OTC - ACTIVE INGREDIENT SECTION

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

Active ingredient (per tablet)

Calcium Carbonate USP 1000mg

OTC - PURPOSE SECTION

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

Purpose

Antacid

WARNINGS SECTION

LOINC: 34071-1Updated: 7/9/2019

Warnings

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 7/9/2019

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: 7/9/2019

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/9/2019

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/9/2019

Other information

  • each tablet contains:elemental calcium 400mg
  • Store below 30°C (86°F)
  • Keep the container tightly closed
  • For calcium and magnesium content see Supplement Facts.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/13/2025

Inactive ingredients

adipic acid, blue 1 lake, dextrose, flavors, magnesium stearate, red 40 lake, maltodextrin, starch, sucralose.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/9/2019

Questions or comments?

1-800-632-6900

Safety Sealed:

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

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Kroger Ultra Strength - FDA Drug Approval Details