SPL v3
SPL
SPL Set ID 7783d6a2-56e3-4542-ad1d-60680e03532b
Route
ORAL
Published
Effective Date 2025-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: AP;043 Shape: round Color: pink Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-13
Description

Calcium carbonate 500 mg (in each chewable tablet)

Purpose

Antacid

Medication Information

Purpose

Antacid

Description

Calcium carbonate 500 mg (in each chewable tablet)

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms
Section 50565-1

Warnings

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

When using this product

  • do not take more than 8 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

Keep out of reach of children.

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 take for symptoms that persist for more than 2 weeks unless advised by a doctor
Product Label

Active Ingredient

Calcium carbonate 500 mg (in each chewable tablet)

Other Information
  • each tablet contains: elemental calcium 200 mg
  • store at room temperature
  • keep the container tightly closed
Inactive Ingredients

Al-lakes (D&C red #27, D&C yellow #10, FD&C blue #1, FD&C yellow #6), dextrose, flavors (cherry, lemon, lime, orange), magnesium stearate, maltodextrin

Questions Or Comments?

call 1-866-399-7227

Structured Label Content

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms
Section 50565-1 (50565-1)

Purpose

Antacid

Warnings

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

When using this product

  • do not take more than 8 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

Keep out of reach of children.

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 take for symptoms that persist for more than 2 weeks unless advised by a doctor
Product Label (Product label)

Active Ingredient (Active ingredient)

Calcium carbonate 500 mg (in each chewable tablet)

Other Information (Other information)
  • each tablet contains: elemental calcium 200 mg
  • store at room temperature
  • keep the container tightly closed
Inactive Ingredients (Inactive ingredients)

Al-lakes (D&C red #27, D&C yellow #10, FD&C blue #1, FD&C yellow #6), dextrose, flavors (cherry, lemon, lime, orange), magnesium stearate, maltodextrin

Questions Or Comments? (Questions or comments?)

call 1-866-399-7227

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:26.817197 · Updated: 2026-03-14T23:09:12.253423