Label: ANTACID- calcium carbonate tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 61010-4408-0, 61010-4408-1, 61010-4408-2 - Packager: Safetec of America, Inc.
- Category: HUMAN OTC DRUG LABEL
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 December 30, 2019
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (per tablet)
- Purpose
- INDICATIONS & USAGE
- Warnings
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel - 750 mg Pouch Label
- Principal Display Panel – 50 Count Carton
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Principal Display Panel – 100 Count Carton
Safetec®
of America, Inc.*Compare to the active
ingredient in TUMS® EXNDC 61010-4408-2
Antacid
Calcium Carbonate 750 mg – Extra Strength
- Fast heartburn relief
- Relieves acid indigestion
PUSH TO OPEN
Dispense
through openingTAMPER EVIDENT UNIT DOSE POUCHES
DO NOT USE IF POUCH IS TORN OR DAMAGED
100 Pouches 2 Tablets per pouch
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INGREDIENTS AND APPEARANCE
ANTACID
calcium carbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-4408 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 750 mg Inactive Ingredients Ingredient Name Strength DEXTROSE (UNII: IY9XDZ35W2) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) PEPPERMINT (UNII: V95R5KMY2B) Product Characteristics Color white (WHITE) Score no score Shape ROUND (ROUND) Size 16mm Flavor Imprint Code AP;052 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61010-4408-0 2 in 1 POUCH; Type 0: Not a Combination Product 12/30/2019 2 NDC:61010-4408-1 50 in 1 BOX 12/30/2019 2 NDC:61010-4408-0 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:61010-4408-2 100 in 1 BOX 12/30/2019 3 NDC:61010-4408-0 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 12/30/2019 Labeler - Safetec of America, Inc. (874965262)