Leader Extra Strength Antacid Tropical Fruit Chewable Tablets

SPL v5

SPL

SPL Set ID 81911f6d-7edf-4183-9720-2f20a5db498d

Route

ORAL

Published

Effective Date 2024-12-17

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Calcium Cation (750 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2019-07-17 Until 2027-09-30

Description

Calcium carbonate 750 mg

Purpose

Antacid

Medication Information

Purpose

Antacid

Description

Calcium carbonate 750 mg

Use(s)

relieves:

acid indigestion
heartburn

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

corn starch, crospovidone, D&C red 27 lake, D&C yellow 10 lake, dextrose, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

Principal Display Panel

ADER

NDC 70000-0431-1

Extra Strength

Antacid Tablets

Calcium Carbonate 750 mg

Tropical Fruit Flavor

COMPARE TO TUMS® EXTRA STRENGTH active ingredient*

Relief of :

Acid Indigestion
Heartburn

96 CHEWABLE TABLETS

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.

If Pregnant Or/breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children

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.

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: 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)

corn starch, crospovidone, D&C red 27 lake, D&C yellow 10 lake, dextrose, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ADER

NDC 70000-0431-1

Extra Strength

Antacid Tablets

Calcium Carbonate 750 mg

Tropical Fruit Flavor

COMPARE TO TUMS® EXTRA STRENGTH active ingredient*

Relief of :

Acid Indigestion
Heartburn

96 CHEWABLE TABLETS

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.

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 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.

Advanced Ingredient Data

[{"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIB", "strengthNumerator": "750", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"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": "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": "D&C RED NO. 27", "unii": "2LRS185U6K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "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: 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": "corn starch, crospovidone, D&C red 27 lake, D&C yellow 10 lake, dextrose, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.", "PRINCIPAL DISPLAY PANEL": "ADER NDC 70000-0431-1 Extra Strength Antacid Tablets Calcium Carbonate 750 mg Tropical Fruit Flavor COMPARE TO TUMS® EXTRA STRENGTH active ingredient* Relief of : Acid Indigestion Heartburn 96 CHEWABLE TABLETS", "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.", "IF PREGNANT OR/BREASTFEEDING,": "ask a health professional before use.", "KEEP OUT OF REACH OF CHILDREN": ".", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:50.435573 · Updated: 2026-03-14T23:09:50.407692