Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 26c742a7-5806-44e0-bef0-c70a9d77dd23
Route
ORAL
Published
Effective Date 2024-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (500 mg)
Inactive Ingredients
Adipic Acid Fd&c Blue No. 1 Dextrose, Unspecified Form Magnesium Stearate Maltodextrin D&c Red No. 27 Starch, Corn Sucralose Fd&c Yellow No. 6 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Imprint: RP101 Shape: round Color: white Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-02-07

Description

Calcium Carbonate USP 1000mg

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Calcium Carbonate USP 1000mg

Uses

relieves:

• heartburn

• sour stomach

• acid indigestion

• upset stomach associated with these symptoms

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 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 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 1000mg

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, D&C Yellow No. 10, dextrose, FD&C Blue No. 1, FD&C Yellow No. 6, flavors, magnesium stearate, maltodextrin, , starch, sucralose,

Questions Or Comments?

1-866-467-2748

Package/label Principal Display Panel

Compare to the Active Ingredient in Ultra Strength Tums®

Premier Value

GLUTEN FREE

ULTRA STRENGTH

Antacid Tablets

CALCIUM CARBONATE USP 1000 mg

Fast Relief of Heartburn, Acid Indigestion & Upset Stomach

ASSORTED FRUIT

Naturally and Artificially Flavored

72 Chewable Tablets

Distributed by

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark, Ultra Strength Tums®

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

Premier Value Ultra Strength Assorted Fruit Antacid Tablets

Premier Value Ultra Strength Assorted Fruit Antacid 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 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 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 1000mg

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, D&C Yellow No. 10, dextrose, FD&C Blue No. 1, FD&C Yellow No. 6, flavors, magnesium stearate, maltodextrin, , starch, sucralose,

Questions Or Comments? (Questions or comments?)

1-866-467-2748

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

Compare to the Active Ingredient in Ultra Strength Tums®

Premier Value

GLUTEN FREE

ULTRA STRENGTH

Antacid Tablets

CALCIUM CARBONATE USP 1000 mg

Fast Relief of Heartburn, Acid Indigestion & Upset Stomach

ASSORTED FRUIT

Naturally and Artificially Flavored

72 Chewable Tablets

Distributed by

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark, Ultra Strength Tums®

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

Premier Value Ultra Strength Assorted Fruit Antacid Tablets

Premier Value Ultra Strength Assorted Fruit Antacid Tablets


Advanced Ingredient Data


Raw Label Data

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