Regular Strength Antacid Caclium Carbonate 150 Chewable Tablets

Regular Strength Antacid Caclium Carbonate 150 Chewable Tablets
SPL v1
SPL
SPL Set ID 3f7fe022-aee9-b899-e063-6394a90afb4e
Route
ORAL
Published
Effective Date 2025-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: AP101 Shape: round Color: white Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-23

Description

Calcium Carbonate USP 500mg

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Calcium Carbonate USP 500mg

Uses

relieves:

• heartburn

• sour stomach

• acid indigestion

• upset stomach associated with these symptoms

Section 50565-1

Keep out of Reach of Children

Section 53413-1

Questions or comments? call toll-free 1-877-225-6999

Manufactured for:

Akron Pharma Inc.,

Fairfield, NJ-07004

www.akronpharma.com

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

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 15 tablets in 24 hours
  • If pregnant do not take more than 10 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 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 500mg

Other Information
  • Each tablet contains: elemental calcium 200 mg
  • Store at room temperature. Keep the container tightly closed

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

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 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

Package/label Principal Display Panel


Structured Label Content

Uses

relieves:

• heartburn

• sour stomach

• acid indigestion

• upset stomach associated with these symptoms

Section 50565-1 (50565-1)

Keep out of Reach of Children

Section 53413-1 (53413-1)

Questions or comments? call toll-free 1-877-225-6999

Manufactured for:

Akron Pharma Inc.,

Fairfield, NJ-07004

www.akronpharma.com

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

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 15 tablets in 24 hours
  • If pregnant do not take more than 10 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 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 500mg

Other Information
  • Each tablet contains: elemental calcium 200 mg
  • Store at room temperature. Keep the container tightly closed

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

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 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

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


Advanced Ingredient Data


Raw Label Data

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