Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID c1171d19-5694-4e6c-9865-40c5f62c4f05
Route
ORAL
Published
Effective Date 2025-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (500 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: RP101 Shape: round Color: red Color: yellow Color: orange Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-02-07

Description

Calcium carbonates USP 500mg

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Calcium carbonates USP 500mg

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 15 tablets in 24 hours

• do not use the maximum dosage for more than 2 weeks.

Directions

• Chew 2-4 tablets as symptoms occur, or as directed by a doctor.

Active Ingredient

Calcium carbonates USP 500mg

Other Information

• Store below 30°C (86°F).

• Keep the container tightly closed

• For calcium and magnesium content see Supplement Facts.

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.

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

Package/label Principal Display Panel

Compare to Tums Regular Strength active ingredient*

NDC 63868-047-15

Quality Choice

Regular Strength

Antacid Tablets

Antacid Calcium Supplement

Calcium Carbonate 500mg

Relieves:

Upset Stomach

Heartburn

Acid Indigestion

Assorted Fruit

150 Chewable Tablets

Quality Choice Regular Strength 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 aretaking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

• do not take more than 15 tablets in 24 hours

• do not use the maximum dosage for more than 2 weeks.

Directions

• Chew 2-4 tablets as symptoms occur, or as directed by a doctor.

Active Ingredient (Active ingredient)

Calcium carbonates USP 500mg

Other Information

• Store below 30°C (86°F).

• Keep the container tightly closed

• For calcium and magnesium content see Supplement Facts.

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.

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 Tums Regular Strength active ingredient*

NDC 63868-047-15

Quality Choice

Regular Strength

Antacid Tablets

Antacid Calcium Supplement

Calcium Carbonate 500mg

Relieves:

Upset Stomach

Heartburn

Acid Indigestion

Assorted Fruit

150 Chewable Tablets

Quality Choice Regular Strength Antacid Tablets


Advanced Ingredient Data


Raw Label Data

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