Label: CALCIUM ANTACID- calcium carbonate tablet, chewable
- NDC Code(s): 48433-106-01
- Packager: Safecor Health, LLC
- This is a repackaged label.
- Source NDC Code(s): 69168-219
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 26, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.
- Keep Out of Reach of Children
- Directions
- Inactive Ingredients
-
Package/Label Principal Display Panel
SAFECOR HEALTH
CALCIUM ANTACID
Regular Strength
500 mg
NDC 48433-106-01
Fruit Flavored Chewable Tablets
Compare to Tums ® Active Ingredient *
This package is not child resistant. For institutional use only.
This product is not manufactured or distributed by GlaxoSmithKline, distributor of Tums®
Questions or comments? Call 1-800-447-1006
100 Unit Dose Chewable Tablets
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INGREDIENTS AND APPEARANCE
CALCIUM ANTACID
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48433-106(NDC:69168-219) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 500 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) DEXTROSE (UNII: IY9XDZ35W2) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Product Characteristics Color YELLOW, ORANGE, PINK, GREEN Score no score Shape ROUND Size 16mm Flavor LIME, CHERRY, ORANGE, LEMON Imprint Code AZ;024 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48433-106-01 100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product 08/25/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 08/25/2014 Labeler - Safecor Health, LLC (828269675) Establishment Name Address ID/FEI Business Operations Safecor Health, LLC 078805287 REPACK(48433-106)