Extra Strength Antacid Relief assorted Fruit

SPL v4

SPL

SPL Set ID 3e008e9e-98e1-413a-b718-5eb0c4367e34

Route

ORAL

Published

Effective Date 2022-01-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Carbonate Ion (750 mg)

Inactive Ingredients

Adipic Acid Starch, Corn Crospovidone D&c Red No. 27 D&c Red No. 30 D&c Yellow No. 10 Dextrose, Unspecified Form Fd&c Blue No. 1 Fd&c Yellow No. 6 Magnesium Stearate Maltodextrin Sucrose Talc

Identifiers & Packaging

Pill Appearance

Imprint: G127 Shape: round Color: pink Color: orange Color: yellow Color: green Size: 16 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2015-08-08

Description

Calcium carbonate 750 mg

Purpose

Antacid

Medication Information

Purpose

Antacid

Description

Calcium carbonate 750 mg

Uses

relieves

acid indigestion
heartburn

Section 50565-1

Section 51945-4

COMPARE TO TUMS^® E-X active ingredient*

NDC21130-127-22

Signature Care

Extra Strength

Antacid Relief Tablets

CALCIUM CARBONATE 750 mg

ASSORTED FRUIT FLAVOR

Chewable
Rich in Calcium
Relief of: Acid Indigestion/Heartburn

96 Tablets

Warnings

Directions

adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.

Other Information

each tablet contains: elemental calcium 300 mg
do not use if printed seal under cap is torn or missing.
store at room temperature. keep the container tightly closed.

Inactive Ingredients

adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc

When Using This Product

do not take more than 10 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.

Active Ingredient (in Each Tablet)

Calcium carbonate 750 mg

Ask A Doctor Or Pharmacist Before Use If You Are

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

If Pregnant Or Breast Feeding, Ask A Health Professional Before Use.

Keep out of reach of children

Structured Label Content

Uses

relieves

acid indigestion
heartburn

Section 50565-1 (50565-1)

Section 51945-4 (51945-4)

COMPARE TO TUMS^® E-X active ingredient*

NDC21130-127-22

Signature Care

Extra Strength

Antacid Relief Tablets

CALCIUM CARBONATE 750 mg

ASSORTED FRUIT FLAVOR

Chewable
Rich in Calcium
Relief of: Acid Indigestion/Heartburn

96 Tablets

Purpose

Antacid

Warnings

Directions

adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.

Other Information (Other information)

each tablet contains: elemental calcium 300 mg
do not use if printed seal under cap is torn or missing.
store at room temperature. keep the container tightly closed.

Inactive Ingredients (Inactive ingredients)

adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc

When Using This Product (When using this product)

do not take more than 10 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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Calcium carbonate 750 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.

If Pregnant Or Breast Feeding, Ask A Health Professional Before Use. (If pregnant or breast-feeding, ask a health professional before use.)

Keep out of reach of children

Advanced Ingredient Data

[{"name": "CARBONATE ION", "unii": "7UJQ5OPE7D", "classCode": "ACTIB", "strengthNumerator": "750", "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": "D&C RED NO. 27", "unii": "2LRS185U6K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 30", "unii": "2S42T2808B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE, UNSPECIFIED FORM", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "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": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves acid indigestion heartburn", "51945-4": "COMPARE TO TUMS ® E-X active ingredient* NDC21130-127-22 Signature Care Extra Strength Antacid Relief Tablets CALCIUM CARBONATE 750 mg ASSORTED FRUIT FLAVOR Chewable Rich in Calcium Relief of: Acid Indigestion/Heartburn 96 Tablets", "Purpose": "Antacid", "Directions": "adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.", "Other information": "each tablet contains: elemental calcium 300 mg do not use if printed seal under cap is torn or missing. store at room temperature. keep the container tightly closed.", "Inactive ingredients": "adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc", "When using this product": "do not take more than 10 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.", "Active ingredient (in each tablet)": "Calcium carbonate 750 mg", "Ask a doctor or pharmacist before use if you are": "presently taking a prescription drug. Antacids may interact with certain prescription drugs.", "If pregnant or breast-feeding, ask a health professional before use.": "Keep out of reach of children"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:57.354848 · Updated: 2026-03-14T23:00:12.227844