Extra Strength Smooth Antacid Tablets

SPL v6

SPL

SPL Set ID 8ed35c3b-9878-4889-90f7-a3973cf806e0

Route

ORAL

Published

Effective Date 2020-10-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Calcium Cation (750 mg)

Inactive Ingredients

Adipic Acid D&c Yellow No. 10 Dextrose, Unspecified Form Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Magnesium Stearate Maltodextrin Starch, Corn Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: RP115 Shape: round Color: pink Color: orange Color: yellow Size: 19 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-10-01

Description

Calcium Carbonate USP 750mg

Purpose

Antacid

Medication Information

Purpose

Antacid

Description

Calcium Carbonate USP 750mg

Uses

relieves:

• heartburn

• sour stomach

• acid indigestion

• upset stomach associated with these symptoms

Warnings

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

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

Directions

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

Active Ingredient

Calcium Carbonate USP 750mg

Other Information

• each tablet contains:calcium 300mg

• Store at room temperature. Keep the container tightly closed

Inactive Ingredients

adipic acid, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Red No. 40 Lake, FD&C Yellow No. 6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose

Safety sealed: Do not use if printed seal under cap is torn or missing

Package/label Principal Display Panel

*Compare to the active ingredient in Extra Strength Tums ^®Smoothies™

EXTRA STRENGTH

Smooth Antacid Tablets

Calcium Carbonate 750 mg

Assorted Fruit

Naturally and Artificially Flavored

For Fast Relief of Heartburn, Acid Indigestion & Upset Stomach

60 Chewable Tablets

Distributed by:

*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark, Extra Strength Tums® Smoothies™

Structured Label Content

Uses

relieves:

• heartburn

• sour stomach

• acid indigestion

• upset stomach associated with these symptoms

Purpose

Antacid

Warnings

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

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

Directions

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

Active Ingredient (Active ingredient)

Calcium Carbonate USP 750mg

Other Information

• each tablet contains:calcium 300mg

• Store at room temperature. Keep the container tightly closed

Inactive Ingredients (Inactive ingredients)

adipic acid, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Red No. 40 Lake, FD&C Yellow No. 6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose

Safety sealed: Do not use if printed seal under cap is torn or missing

Package/label Principal Display Panel (Package/Label Principal Display Panel)

*Compare to the active ingredient in Extra Strength Tums ^®Smoothies™

EXTRA STRENGTH

Smooth Antacid Tablets

Calcium Carbonate 750 mg

Assorted Fruit

Naturally and Artificially Flavored

For Fast Relief of Heartburn, Acid Indigestion & Upset Stomach

60 Chewable Tablets

Distributed by:

*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark, Extra Strength Tums® Smoothies™

Advanced Ingredient Data

[{"name": "ADIPIC ACID", "unii": "76A0JE0FKJ", "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 RED NO. 40", "unii": "WZB9127XOA", "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": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIB", "strengthNumerator": "750", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves: • heartburn • sour stomach • acid indigestion • upset stomach associated with these symptoms", "Purpose": "Antacid", "Warnings": "Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. 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", "Directions": "• adults and children 12 years of age and over: chew 2-4 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.", "Active ingredient": "Calcium Carbonate USP 750mg", "Other Information": "• each tablet contains: calcium 300mg • Store at room temperature. Keep the container tightly closed", "Inactive ingredients": "adipic acid, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Red No. 40 Lake, FD&C Yellow No. 6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose Safety sealed: Do not use if printed seal under cap is torn or missing", "Package/Label Principal Display Panel": "*Compare to the active ingredient in Extra Strength Tums ® Smoothies™ EXTRA STRENGTH Smooth Antacid Tablets Calcium Carbonate 750 mg Assorted Fruit Naturally and Artificially Flavored For Fast Relief of Heartburn, Acid Indigestion & Upset Stomach 60 Chewable Tablets Distributed by: *This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark, Extra Strength Tums® Smoothies™"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:13.568286 · Updated: 2026-03-14T23:13:18.140905