Active Ingredient (In Each Tablet)
Calcium Carbonate 500 mg
Calcium Carbonate Tablet, Chewable
FDA Label NDC 51376-127
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Blessings International for the product Calcium Carbonate (NDC 51376-127). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid
Uses
temporarily relieves:
- acid indigestion
- heartburn
- sour stomach
Warnings
Ask a doctor before use if you
- have kidney disease
- are taking prescription drugs; antacids may interact with certain prescription drugs
Stop use and ask a doctor if • symptoms last more than 2 weeks.
When using this product • do not use the maximum dosage for more than 2 weeks
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Directions
For adults and children 12 years and older, chew 2-4 tablets as symptoms occur
- repeat hourly if symptoms return, or as directed by a physician
- do not take more than 15 tablets in a 24 hour period
- children under 12 years: consult a doctor
Other Information
- each tablet contains: calcium 200 mg
- store at room temperature
Inactive Ingredients
assorted flavors, dextrose, D&C Yellow #10 lake, FD&C Blue #1 lake, FD&C Red #40 lake, FD&C Yellow #6 lake, magnesium stearate, maltodextrin. May also contain cellulose, FD&C Yellow #5 lake (tartrazine), stearic acid, sugar.
Package Label
1 (763 Ble)
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