MedPath

Ultra Strength

Kroger Ultra Strength 72 Chewable Tablets Drug Facts

Approved
Approval ID

2931d427-b2be-4db9-a58d-ff89c221ff51

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 Code30142-108
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 (7)

DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STEVIA REBAUDIANA LEAFInactive
Code: 6TC6NN0876
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**®**

**NDC#**30142-108-72

COMPARE TO the active ingredient in Ultra Strength TUMS**®**

*See back panel

Ultra Strength

Antacid Tablets

NATURALLY-DERIVED INGREDIENTS

Calcium Carbonate 1000 mg

**FAST RELIEF:Upset Stomach,**Heartburn and Acid Indigestion

Peppermint

Naturally Flavored

GLUTEN FREE

72 CHEWABLE TABLETS

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, Warren, NJ 07059. GlaxoSmithKline LLC is not affiliated with The Kroger Co. or this product.

Kroger Natural Antacid Tablets 72 Chewable Tablets

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/2/2019

Uses

relieves

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/2/2019

Active ingredient (per tablet)

Calcium Carbonate USP 1000mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/2/2019

Purpose

Antacid

WARNINGS SECTION

LOINC: 34071-1Updated: 12/2/2019

Warnings

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 12/2/2019

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 12/2/2019

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: 12/2/2019

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/2/2019

Directions

***adults and children 12years of age and over:**chew 2-3 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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 12/2/2019

Other information

***each tablets 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, maltodextrin, natural peppermint flavor, starch, stearic acid, stevia extract.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 12/2/2019

Questions or comments?

1-866-467-2748

Safety Sealed

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

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Ultra Strength - FDA Drug Approval Details