Label: EXTRA STRENGTH ANTACID- calcium carbonate tablet, chewable
- NDC Code(s): 51013-323-54
- Packager: PuraCap Pharmaceutical LLC
- 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 December 13, 2017
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- Active ingredient (per tablet)
- Purpose
- Uses
- Warnings
- When using this product
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH ANTACID
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51013-323 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 750 mg Inactive Ingredients Ingredient Name Strength DEXTROSE (UNII: IY9XDZ35W2) PEPPERMINT (UNII: V95R5KMY2B) MALTODEXTRIN (UNII: 7CVR7L4A2D) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND Size 16mm Flavor PEPPERMINT Imprint Code AP;052 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51013-323-54 15 in 1 CARTON 12/13/2017 1 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 12/13/2017 Labeler - PuraCap Pharmaceutical LLC (962106329) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical Inc. 078301063 manufacture(51013-323)