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Drug Facts
Calcium Carbonate Tablet, Chewable
FDA Label NDC 55154-6751
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Calcium Carbonate (NDC 55154-6751). 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 other, active ingredient (in each tablet), purpose, use, ask a doctor before use if you have, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Calcium Carbonate USP 500mg
Purpose
Antacid
Use
temporarily relieves:
▪ Heartburn▪ Sour Stomach▪ Acid Indigestion▪ Upset Stomach Associated With These Symptoms
Ask A Doctor Before Use If You Have
▪ kidney disease▪ taking any prescription drugs; antacids may interact with certain prescription drugs
Otc - When Using
When using this product do not take more than 15 tablets in a 24 hour period or use the maximum dosage of this product for more than 2 weeks.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Chew 2-4 tablets as symptoms occur, repeat hourly if needed
Other Information
▪ do not use if packet is opened or torn▪ Store at controlled room temperature 15° to 30° C (59° to 86° F)▪ Calcium content per tablet: 200mg
Inactive Ingredients
FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, orange flavor, sorbitol
Questions?
1-866-651-3660 Monday-Friday 8:00am-5:00pm EST
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Overbagged with 10 chewable tablets per bag, NDC 55154-6751-0
WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.
Mfg. by: Allegiant Health, Deer Park, NY 11729
Dist. By: Hospak® Unit Dose Products, Huntley, IL
60142
Hospak®
Distributed By:
Cardinal Health
Dublin, OH 43017
L33753910124
Principal Display Panel
NDC 55154-6751-0
CALCIUM CARBONATE 500mg
(Calcium, Elemental 200mg)
CHEWABLE ANTACID TABLETS
10 TABLETS
500mg Bag Label (8109dd2b 875c 40eb 82ac D3780bc0c437 00)
* Please review the disclaimer below.
