Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID fdc3a8b9-3edf-4339-9656-623973b32ea5

Route

ORAL

Published

Effective Date 2020-01-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Calcium Cation (750 mg)

Inactive Ingredients

Dextrose Magnesium Stearate Maltodextrin Peppermint

Identifiers & Packaging

Pill Appearance

Imprint: AP;052 Shape: round Color: white Size: 16 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2019-12-30

Description

Calcium Carbonate USP 750 mg

Purpose

Antacid

Medication Information

Indications and Usage

Uses relieves

heartburn
acid indigestion
sour stomach
upset stomach associated with these symptoms

Purpose

Antacid

Description

Calcium Carbonate USP 750 mg

Section 50568-5

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Other Information

each tablet contains: calcium 300 mg
store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

dextrose, flavor (peppermint), magnesium stearate, maltodextrin

Questions Or Comments?

Call toll free: 1-800-456-7077

When Using This Product

do not take more than 10 tablets in 24 hours
if pregnant do not take more than 6 tablets in 24 hours
do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Active Ingredient (per Tablet)

Calcium Carbonate USP 750 mg

Keep Out of Reach of Children.

adults and children 12 years of age and over: chew 2-4 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

Principal Display Panel – 50 Count Carton

Safetec^®

of America, Inc.

*Compare to the active

ingredient in TUMS^® EX

NDC 61010-4408-1

Antacid

Calcium Carbonate 750 mg – Extra Strength

Fast heartburn relief
Relieves acid indigestion

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

50 Pouches 2 Tablets per pouch

Principal Display Panel 750 Mg Pouch Label

Safetec

of America, Inc.

DO NOT USE IF POUCH IS TORN OR DAMAGED

Manufactured for Safetec of America, Inc.

Buffalo NY 14215

EXTRA STRENGTH

Antacid

Calcium Carbonate 750 mg

2 Chewable Tablets

Principal Display Panel – 100 Count Carton

Safetec^®

of America, Inc.

*Compare to the active

ingredient in TUMS^® EX

NDC 61010-4408-2

Antacid

Calcium Carbonate 750 mg – Extra Strength

Fast heartburn relief
Relieves acid indigestion

PUSH TO OPEN

Dispense

through opening

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

100 Pouches 2 Tablets per pouch

Structured Label Content

Indications and Usage (34067-9)

Uses relieves

heartburn
acid indigestion
sour stomach
upset stomach associated with these symptoms

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Purpose

Antacid

Other Information (Other information)

each tablet contains: calcium 300 mg
store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

dextrose, flavor (peppermint), magnesium stearate, maltodextrin

Questions Or Comments? (Questions or comments?)

Call toll free: 1-800-456-7077

When Using This Product (When using this product)

do not take more than 10 tablets in 24 hours
if pregnant do not take more than 6 tablets in 24 hours
do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Active Ingredient (per Tablet) (Active ingredient (per tablet))

Calcium Carbonate USP 750 mg

Keep Out of Reach of Children. (Keep out of reach of children.)

adults and children 12 years of age and over: chew 2-4 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

Principal Display Panel – 50 Count Carton

Safetec^®

of America, Inc.

*Compare to the active

ingredient in TUMS^® EX

NDC 61010-4408-1

Antacid

Calcium Carbonate 750 mg – Extra Strength

Fast heartburn relief
Relieves acid indigestion

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

50 Pouches 2 Tablets per pouch

Principal Display Panel 750 Mg Pouch Label (Principal Display Panel - 750 mg Pouch Label)

Safetec

of America, Inc.

DO NOT USE IF POUCH IS TORN OR DAMAGED

Manufactured for Safetec of America, Inc.

Buffalo NY 14215

EXTRA STRENGTH

Antacid

Calcium Carbonate 750 mg

2 Chewable Tablets

Principal Display Panel – 100 Count Carton

Safetec^®

of America, Inc.

*Compare to the active

ingredient in TUMS^® EX

NDC 61010-4408-2

Antacid

Calcium Carbonate 750 mg – Extra Strength

Fast heartburn relief
Relieves acid indigestion

PUSH TO OPEN

Dispense

through opening

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

100 Pouches 2 Tablets per pouch

Advanced Ingredient Data

[{"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIB", "strengthNumerator": "750", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DEXTROSE", "unii": "IY9XDZ35W2", "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": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms", "50568-5": "Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.", "Purpose": "Antacid", "Other information": "each tablet contains: calcium 300 mg store at room temperature 15°-30°C (59°-86°F)", "Inactive ingredients": "dextrose, flavor (peppermint), magnesium stearate, maltodextrin", "Questions or comments?": "Call toll free: 1-800-456-7077", "When using this product": "do not take more than 10 tablets in 24 hours if pregnant do not take more than 6 tablets in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor", "Active ingredient (per tablet)": "Calcium Carbonate USP 750 mg", "Keep out of reach of children.": "adults and children 12 years of age and over: chew 2-4 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", "Principal Display Panel – 50 Count Carton": "Safetec ® of America, Inc. *Compare to the active ingredient in TUMS ® EX NDC 61010-4408-1 Antacid Calcium Carbonate 750 mg – Extra Strength Fast heartburn relief Relieves acid indigestion TAMPER EVIDENT UNIT DOSE POUCHES DO NOT USE IF POUCH IS TORN OR DAMAGED 50 Pouches 2 Tablets per pouch", "Principal Display Panel - 750 mg Pouch Label": "Safetec of America, Inc. DO NOT USE IF POUCH IS TORN OR DAMAGED Manufactured for Safetec of America, Inc. Buffalo NY 14215 EXTRA STRENGTH Antacid Calcium Carbonate 750 mg 2 Chewable Tablets", "Principal Display Panel – 100 Count Carton": "Safetec ® of America, Inc. *Compare to the active ingredient in TUMS ® EX NDC 61010-4408-2 Antacid Calcium Carbonate 750 mg – Extra Strength Fast heartburn relief Relieves acid indigestion PUSH TO OPEN Dispense through opening TAMPER EVIDENT UNIT DOSE POUCHES DO NOT USE IF POUCH IS TORN OR DAMAGED 100 Pouches 2 Tablets per pouch"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:02.699645 · Updated: 2026-03-14T22:55:55.934342