Ultra Strength Assorted Fruits Flavor Chewable Tablets

SPL v6

SPL

SPL Set ID 35b3d9d0-b04d-4f6d-b99d-435233803d4b

Route

ORAL

Published

Effective Date 2020-10-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Calcium Cation (1000 mg)

Inactive Ingredients

Adipic Acid D&c Red No. 27 D&c Yellow No. 10 Dextrose, Unspecified Form Fd&c Blue No. 1 Fd&c Yellow No. 6 Magnesium Stearate Maltodextrin Starch, Corn Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: RP103 Shape: round Color: red Color: yellow Color: orange Color: green Size: 19 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-09-30

Description

Calcium Carbonate USP 1,000mg

Purpose

Antacid

Medication Information

Purpose

Antacid

Description

Calcium Carbonate USP 1,000mg

Uses

relieves

heartburn
sour stomach
acid indigestion
upset stomach associated with these symptoms

Warnings

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

When using this product

do not take more than 7 tablets in 24 hours
if pregnant do not take more than 5 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 2-3 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

Other Information

each tablet contains:elemental calcium 400mg
store at room temperature. Keep the container tightly closed

Inactive Ingredients

adipic acid, D&C Red No. 27 Lake, D&C Yellow No.10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Yellow No. 6, flavor, magnesium stearate, maltodextrin, starch, sucralose.

Questions Or Comments?

1-866-467-2748

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

Active Ingredient (per Tablet)

Calcium Carbonate USP 1,000mg

Package Label 72 Chewable Tablets

Package/label Principal Display Panel

* Compare to the active ingredients in Ultra Strength Tums ^®

ULTRA STRENGTH

Antacid Tablets

Calcium Carbonate 1000mg

Relieves of:

Acid indigestion
Sour Stomach
Heartburn

Assorted Fruit Flavors

GLUTEN-FREE

Distributed by:

*This product is not manufactured and distributed by GlaxoSmithKline LLC, owner of the registered trademark, Ultra Strength Tums ^®

Package Label 160 Chewable Tablets

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 are presentlytaking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

do not take more than 7 tablets in 24 hours
if pregnant do not take more than 5 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 2-3 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

Other Information (Other information)

each tablet contains:elemental calcium 400mg
store at room temperature. Keep the container tightly closed

Inactive Ingredients (Inactive ingredients)

adipic acid, D&C Red No. 27 Lake, D&C Yellow No.10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Yellow No. 6, flavor, magnesium stearate, maltodextrin, starch, sucralose.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

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

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

Calcium Carbonate USP 1,000mg

Package Label 72 Chewable Tablets

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

* Compare to the active ingredients in Ultra Strength Tums ^®

ULTRA STRENGTH

Antacid Tablets

Calcium Carbonate 1000mg

Relieves of:

Acid indigestion
Sour Stomach
Heartburn

Assorted Fruit Flavors

GLUTEN-FREE

Distributed by:

*This product is not manufactured and distributed by GlaxoSmithKline LLC, owner of the registered trademark, Ultra Strength Tums ^®

Package Label 160 Chewable Tablets

Advanced Ingredient Data

[{"name": "ADIPIC ACID", "unii": "76A0JE0FKJ", "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": "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 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": "1000", "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 presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 7 tablets in 24 hours if pregnant do not take more than 5 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 2-3 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", "Other information": "each tablet contains: elemental calcium 400mg store at room temperature. Keep the container tightly closed", "Inactive ingredients": "adipic acid, D&C Red No. 27 Lake, D&C Yellow No.10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Yellow No. 6, flavor, magnesium stearate, maltodextrin, starch, sucralose.", "Questions or comments?": "1-866-467-2748 SAFETY SEALED: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING", "Active ingredient (per tablet)": "Calcium Carbonate USP 1,000mg", "Package/Label Principal Display Panel": "* Compare to the active ingredients in Ultra Strength Tums ® ULTRA STRENGTH Antacid Tablets Calcium Carbonate 1000mg Relieves of: Acid indigestion Sour Stomach Heartburn Assorted Fruit Flavors GLUTEN-FREE Distributed by: *This product is not manufactured and distributed by GlaxoSmithKline LLC, owner of the registered trademark, Ultra Strength Tums ® Package Label 160 Chewable Tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:10.209860 · Updated: 2026-03-14T23:13:16.476899