Label: ANTACID- calcium carbonate tablet, chewable
- NDC Code(s): 17714-041-01
- Packager: Advance Pharmaceutical Inc.
- 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, 2019
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- kidney stones
- a calcium-restricted diet
ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.
Stop use and ask a doctor if symptoms last more than 2 weeks.
If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
- Questions or Comments
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTACID
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17714-041 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 DEXTROSE (UNII: IY9XDZ35W2) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CHERRY (UNII: BUC5I9595W) Product Characteristics Color white Score score with uneven pieces Shape ROUND Size 16mm Flavor CHERRY Imprint Code AP;041 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17714-041-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/30/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 11/30/2007 Labeler - Advance Pharmaceutical Inc. (078301063) Registrant - Advance Pharmaceutical Inc. (078301063) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical Inc. 078301063 manufacture(17714-041)