d04c7485-637b-460b-aeed-dce739c82a6c

SPL v1
SPL
SPL Set ID d04c7485-637b-460b-aeed-dce739c82a6c
Route
oral
Published
Effective Date 2023-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
carbonate ion (500 mg)
Inactive Ingredients
d&c yellow no. 10 aluminum lake fd&c blue no. 1 aluminum lake magnesium stearate sorbitol 5-methyl-1,3,5-triphenyl-2-pyrazoline

Identifiers & Packaging

Pill Appearance
Imprint: NO Shape: round Color: green Size: 15 mm Score: 4
Marketing Status
otc monograph final active Since 2023-03-08
Purpose

Antacid

Description

Calcium Carbonate 500mg

Medication Information

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 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. 
Purpose

Antacid

Directions
  • adults and children 12 years of age and over: chew 2-4 tablets as symtoms occur, or as directed by a doctor
  • do not take for symtoms that persist for more than 2 weeks unless advised by a doctor 
Other Information
  • each tablet contains: elemental calcium 200 mg.
  • Store at room temperature. Keep the container tightly closed.
Inactive Ingredients

D&C Yellow No.10 lake, FD&C Blue No.1 lake, flavor, magnesium stearate, sorbitol, sucralose.

Description

Calcium Carbonate 500mg

Use

Relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms 

Section 50565-1

Keep out of of reach of children

Product Label

Questions Or Comments?

1-888-543-4199   

Active Ingredient (per Tablet)

Calcium Carbonate 500mg

Structured Label Content

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 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. 
Purpose

Antacid

Directions
  • adults and children 12 years of age and over: chew 2-4 tablets as symtoms occur, or as directed by a doctor
  • do not take for symtoms that persist for more than 2 weeks unless advised by a doctor 
Other Information (Other information)
  • each tablet contains: elemental calcium 200 mg.
  • Store at room temperature. Keep the container tightly closed.
Inactive Ingredients (Inactive ingredients)

D&C Yellow No.10 lake, FD&C Blue No.1 lake, flavor, magnesium stearate, sorbitol, sucralose.

Use (USE)

Relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms 

Section 50565-1 (50565-1)

Keep out of of reach of children

Product Label (Product label)

Questions Or Comments? (Questions or comments?)

1-888-543-4199   

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

Calcium Carbonate 500mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:36.947290 · Updated: 2026-03-14T23:01:06.342894