Extra Strength Smooth Antacid Calcium Carbonate Tablets

SPL v3

SPL

SPL Set ID f74e1fc2-9d8a-4839-9403-f757cbd15af9

Route

ORAL

Published

Effective Date 2020-01-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Carbonate Ion (750 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: RP115 Shape: round Color: red Color: blue Color: purple Size: 19 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2020-01-13

Description

Calcium Carbonate USP 750mg

Purpose

Antacid

Medication Information

Purpose

Antacid

Description

Calcium Carbonate USP 750mg

Uses

relieves

•
heartburn
•
acid indigestion
•
sour stomach
•
upset stomach associated with these symptoms

Warnings

Ask a doctor or pharmacist before use if you are presently 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 the tablets whole.
•
do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Questions?

1-866-467-2748

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

Other Information

•
each tablet contains: elemental calcium 300mg
•
store at room temperature. Keep the container tightly closed

Inactive Ingredients

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

Active Ingredient (per Tablet)

Calcium Carbonate USP 750mg

Package/label Principal Display Panel

NDC# 68016-695-60

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

EXTRA STRENGTH

Smooth Antacid Tablets

Calcium Carbonate USP 750 mg

Fas Relief of Upset Stomach, Heartburn and Acid Indigestion

ASSORTED BERRY

Naturally and Artificially Flavored

60 Chewable Tablets

K PAREVE

GLUTEN- FREE

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by GlaxoSmithKline, the distributor of Extra Strength Tums® Smoothies™.

Structured Label Content

Uses

relieves

•
heartburn
•
acid indigestion
•
sour stomach
•
upset stomach associated with these symptoms

Purpose

Antacid

Warnings

Ask a doctor or pharmacist before use if you are presently 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 the tablets whole.
•
do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Questions?

1-866-467-2748

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

Other Information (Other information)

•
each tablet contains: elemental calcium 300mg
•
store at room temperature. Keep the container tightly closed

Inactive Ingredients (Inactive ingredients)

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

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

Calcium Carbonate USP 750mg

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

NDC# 68016-695-60

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

EXTRA STRENGTH

Smooth Antacid Tablets

Calcium Carbonate USP 750 mg

Fas Relief of Upset Stomach, Heartburn and Acid Indigestion

ASSORTED BERRY

Naturally and Artificially Flavored

60 Chewable Tablets

K PAREVE

GLUTEN- FREE

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by GlaxoSmithKline, the distributor of Extra Strength Tums® Smoothies™.

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": "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": "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": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves • heartburn • acid indigestion • sour stomach • upset stomach associated with these symptoms", "Purpose": "Antacid", "Warnings": "Ask a doctor or pharmacist before use if you are presently 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 the tablets whole. • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor", "Questions?": "1-866-467-2748 Safety sealed: Do not use if printed seal under cap is torn or missing", "Other information": "• each tablet contains: elemental calcium 300mg • store at room temperature. Keep the container tightly closed", "Inactive ingredients": "adipic acid, dextrose, FD&C Blue No. 1 Lake, FD&C Red No. 40 Lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.", "Active ingredient (per tablet)": "Calcium Carbonate USP 750mg", "Package/Label Principal Display Panel": "NDC# 68016-695-60 Compare to the active ingredient in Extra Strength Tums® Smoothies ™ EXTRA STRENGTH Smooth Antacid Tablets Calcium Carbonate USP 750 mg Fas Relief of Upset Stomach, Heartburn and Acid Indigestion ASSORTED BERRY Naturally and Artificially Flavored 60 Chewable Tablets K PAREVE GLUTEN- FREE Distributed By: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 *This product is not manufactured or distributed by GlaxoSmithKline, the distributor of Extra Strength Tums® Smoothies™."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:45.831637 · Updated: 2026-03-14T22:59:51.166569