Label: ANTACID EXTRA STRENGTH ASSORTED FRUIT- calcium antacid tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 67091-229-08 - Packager: WinCo Foods, 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 January 14, 2022
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- Active ingredient (in each tablet)
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Warnings
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTACID EXTRA STRENGTH ASSORTED FRUIT
calcium antacid tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-229 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 750 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, UNSPECIFIED FORM (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 pink (Reddish pink) , orange, yellow, green Score no score Shape ROUND Size 16mm Flavor FRUIT (lemon, lime, cherry, orange) Imprint Code G127 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67091-229-08 3 in 1 CARTON 12/12/2014 1 8 in 1 PACKAGE; 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 12/12/2014 Labeler - WinCo Foods, LLC (056098817)