MedPath

Kroger Ultra Strength

Ultra Strength Antacid Calcium Carbonate 72 Chewable Tablets

Approved
Approval ID

b60ced06-725c-4dae-abbf-21cab9e431f9

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 Code30142-307
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 (11)

ADIPIC ACIDInactive
Code: 76A0JE0FKJ
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
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

NDC30142-307-72

Kroger**®**

FAST RELIEF OF UPSET STOMACH, HEARTBURN AND ACID INDIGESTION

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

See back panel

ULTRA STRENGTH

Antacid Tablets

Antacid/Calcium Supplement

CALCIUM CARBONATE 1000 mg

Assorted Fruit Flavor

Naturally and Artificially Flavored

72 CHEWABLE TABLETS

K PAREVE

Our Pharmacists Recommend

GLUTEN- FREE

DISTRIBUTED BY:

THE KROGER CO. CINCINNATI, OHIO 45202

1800-632-6900

www.kroger.com

*Tums® is registered trademark of GlaxoSmithKline LLC, GlaxoSmithKline LLC is not affiliated with The Kroger Co. or this product.

Kroger Ultra Strength Assorted Fruit 72 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 1000mg

OTC - PURPOSE SECTION

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

Purpose

Antacid

WARNINGS SECTION

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

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: 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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/9/2019

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

adipic acid, D&C Red No. 27, D&C Yellow No. 10, dextrose, FD&C Blue No. 1, FD&C Yellow No. 6, flavors, magnesium stearate, maltodextrin, starch, sucralose.

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