extra strength smooth antacid assorted fruit chewable tablets

SPL v3

SPL

SPL Set ID 20c07169-9c9d-4c3a-b6dd-f6874c2de814

Route

oral

Published

Effective Date 2020-01-28

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: green Color: orange Color: yellow Size: 19 mm Score: 1

Marketing Status

otc monograph final active Since 2020-01-28

Purpose

Antacid

Description

Calcium Carbonate USP 750 mg

Medication Information

Uses

relieves:

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

Purpose

Antacid

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 persists for more than 2 weeks unless advised by a doctor

Other Information

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

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

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.

Description

Calcium Carbonate USP 750 mg

Principal Display Panel

Premier Value^®

NDC 68016-697-60

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

EXTRA STRENGTH

Smooth Antacid

CALCIUM CARBONATE USP 750 mg

Assorted Fruit

Naturally and Artificially Flavored

Fast Relief of Upset Stomach, Heartburn and Acid Indigestion

60 Chewable Tablets

GLUTEN-FREE

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

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

Questions Or Comments?

1-866-467-2748

When Using This Product

•
do not take more than 10 tablets in a 24-hour period
•
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

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

Uses

relieves:

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

Purpose

Antacid

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 persists for more than 2 weeks unless advised by a doctor

Other Information (Other information)

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

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

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.

Principal Display Panel

Premier Value^®

NDC 68016-697-60

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

EXTRA STRENGTH

Smooth Antacid

CALCIUM CARBONATE USP 750 mg

Assorted Fruit

Naturally and Artificially Flavored

Fast Relief of Upset Stomach, Heartburn and Acid Indigestion

60 Chewable Tablets

GLUTEN-FREE

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

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

Questions Or Comments? (Questions or comments?)

1-866-467-2748

When Using This Product (When using this product)

•
do not take more than 10 tablets in a 24-hour period
•
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

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": "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": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves: • Heartburn • acid indigestion • sour stomach • upset stomach associated with these symptoms", "Purpose": "Antacid", "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 persists for more than 2 weeks unless advised by a doctor", "Other information": "• each tablet contains: calcium 300 mg • store at room temperature. keep the container tightly closed. DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING", "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.", "Questions or comments?": "1-866-467-2748", "Principal Display Panel": "Premier Value ® NDC 68016-697-60 *Compare to active ingredient Extra Strength Tums ® Smoothies™ EXTRA STRENGTH Smooth Antacid CALCIUM CARBONATE USP 750 mg Assorted Fruit Naturally and Artificially Flavored Fast Relief of Upset Stomach, Heartburn and Acid Indigestion 60 Chewable Tablets GLUTEN-FREE Distributed By: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Extra Strength Tums® Smoothies™.", "When using this product": "• do not take more than 10 tablets in a 24-hour period • 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", "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: 2026-02-15T11:59:45.833673 · Updated: 2026-03-14T22:59:52.177031