Label: ALKUMS ANTACID- calcium carbonate tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 53041-126-17 - Packager: Guardian Drug Company
- 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 17, 2020
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Ask a doctor or pharmacist before use if you are
taking a prescription drug. Antacids may interact with certain prescriptiom drugs.
- Directions
- Other information
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ALKUMS ANTACID
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53041-126 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE 500 mg Inactive Ingredients Ingredient Name Strength ADIPIC ACID (UNII: 76A0JE0FKJ) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 30 (UNII: 2S42T2808B) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) DEXTROSE (UNII: IY9XDZ35W2) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color orange, yellow, green, pink (reddish pink) Score no score Shape ROUND Size 16mm Flavor FRUIT (Orange, cherry, lemon, lime) Imprint Code GDC126 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53041-126-17 150 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 02/01/2012 Labeler - Guardian Drug Company (119210276)