FDA Label for Calcium Carbonate Chewable Antacid

View Indications, Usage & Precautions

Calcium Carbonate Chewable Antacid Product Label

The following document was submitted to the FDA by the labeler of this product Nucare Pharmaceuticals,inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet)



Calcium Carbonate 500 mg


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

If pregnant or breast feeding, ask a health professional before use.


Directions



• do not exceed recommended dose
• adults and children 12 years of age 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
• for institutional use only
Tamper Evident: Do not use if imprinted seal under cap is missing or broken.


Inactive Ingredients



assorted flavors, dextrose, D and C Yellow no. 10 lake, FD and C Blue no. 1 lake, FD and C Red no. 40 lake, FD and C Yellow no. 6 lake, magnesium stearate, maltodextrin. May also contain cellulose, FD and C Yellow no. 5 lake (tartrazine), stearic acid, sugar.


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