Ultra Strength Antacid Assorted Berry

SPL v2

SPL

SPL Set ID 1e987226-02fa-9c10-e063-6294a90a83bf

Route

ORAL

Published

Effective Date 2025-02-04

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Calcium Cation (1000 mg)

Inactive Ingredients

Adipic Acid Starch, Corn Crospovidone Dextrose, Unspecified Form Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Maltodextrin Sucrose Talc Fd&c Red No. 40 Aluminum Lake

Identifiers & Packaging

Pill Appearance

Imprint: G171 Shape: round Color: blue Color: pink Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-02-04

Description

Calcium carbonate 1000 mg

Purpose

Antacid

Medication Information

Purpose

Antacid

Description

Calcium carbonate 1000 mg

Use(s)

relieves:

acid indigestion
heartburn

Warnings

Directions

adults and children 12 years of age and over: wet in mouth before chewing, chew 2-3 tablets as symptoms occur, or as directed by a doctor.

Other Information

each tablet contains: elemental calcium 400 mg, magnesium 10 mg
do not use if printed seal under the cap is torn or missing
store at room temperature. keep the container tightly closed.

Inactive Ingredients

adipic acid, corn starch, crospovidone, dextrose, FD&C blue 1 lake, FD&C red 40 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

Principal Display Panel

NDC 72476-178-23

CAREOne™

Compare to the active ingredient in Tums^® Ultra Strength 1000 Assorted Berries*

ULTRA STRENGTH

CALCIUM ANTACID

Calcium Carbonate 1000 mg

Assorted Berries Flavors

Fast Relief of:

Heartburn and

Acid Indigestion

Gluten Free

72 CHEWABLE TABLETS

When Using This Product

do not take more than 7 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

If Pregnant Or/breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children

Active Ingredient (in Each Tablet)

Calcium carbonate 1000 mg

Ask A Doctor Or Pharmacist Before Use If You Are

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

Structured Label Content

Use(s) (USE(S))

relieves:

acid indigestion
heartburn

Purpose (PURPOSE)

Antacid

Warnings (WARNINGS)

Directions (DIRECTIONS)

adults and children 12 years of age and over: wet in mouth before chewing, chew 2-3 tablets as symptoms occur, or as directed by a doctor.

Other Information (OTHER INFORMATION)

each tablet contains: elemental calcium 400 mg, magnesium 10 mg
do not use if printed seal under the cap is torn or missing
store at room temperature. keep the container tightly closed.

Inactive Ingredients (INACTIVE INGREDIENTS)

adipic acid, corn starch, crospovidone, dextrose, FD&C blue 1 lake, FD&C red 40 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 72476-178-23

CAREOne™

Compare to the active ingredient in Tums^® Ultra Strength 1000 Assorted Berries*

ULTRA STRENGTH

CALCIUM ANTACID

Calcium Carbonate 1000 mg

Assorted Berries Flavors

Fast Relief of:

Heartburn and

Acid Indigestion

Gluten Free

72 CHEWABLE TABLETS

When Using This Product (WHEN USING THIS PRODUCT)

do not take more than 7 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

If Pregnant Or/breastfeeding, (IF PREGNANT OR/BREASTFEEDING,)

ask a health professional before use.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (in each tablet))

Calcium carbonate 1000 mg

Ask A Doctor Or Pharmacist Before Use If You Are (ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE)

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

Advanced Ingredient Data

[{"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIB", "strengthNumerator": "1000", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ADIPIC ACID", "unii": "76A0JE0FKJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE, UNSPECIFIED FORM", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40 ALUMINUM LAKE", "unii": "6T47AS764T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "relieves: acid indigestion heartburn", "PURPOSE": "Antacid", "WARNINGS": ".", "DIRECTIONS": "adults and children 12 years of age and over: wet in mouth before chewing, chew 2-3 tablets as symptoms occur, or as directed by a doctor.", "OTHER INFORMATION": "each tablet contains: elemental calcium 400 mg, magnesium 10 mg do not use if printed seal under the cap is torn or missing store at room temperature. keep the container tightly closed.", "INACTIVE INGREDIENTS": "adipic acid, corn starch, crospovidone, dextrose, FD&C blue 1 lake, FD&C red 40 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.", "PRINCIPAL DISPLAY PANEL": "NDC 72476-178-23 CAREOne™ Compare to the active ingredient in Tums ® Ultra Strength 1000 Assorted Berries* ULTRA STRENGTH CALCIUM ANTACID Calcium Carbonate 1000 mg Assorted Berries Flavors Fast Relief of: Heartburn and Acid Indigestion Gluten Free 72 CHEWABLE TABLETS ", "WHEN USING THIS PRODUCT": "do not take more than 7 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.", "IF PREGNANT OR/BREASTFEEDING,": "ask a health professional before use.", "KEEP OUT OF REACH OF CHILDREN": ".", "ACTIVE INGREDIENT (in each tablet)": "Calcium carbonate 1000 mg", "ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE": "presently taking a prescription drug. Antacids may interact with certain prescription drugs."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:28.506347 · Updated: 2026-03-14T23:07:22.014703