Label: ULTRA STRENGTH ANTACID TROPICAL FRUIT- calcium antacid tablet, chewable
- NDC Code(s): 69842-371-68, 69842-371-75
- Packager: CVS
- 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 October 3, 2017
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- Active ingredient (in each tablet)
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Warnings
- Directions
- Inactive ingredients
- PDP
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INGREDIENTS AND APPEARANCE
ULTRA STRENGTH ANTACID TROPICAL FRUIT
calcium antacid tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-371 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 1000 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) DEXTROSE (UNII: IY9XDZ35W2) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color pink, orange, yellow, white Score no score Shape ROUND Size 16mm Flavor FRUIT (bananna, orange, pineapple orange, punch) Imprint Code G171 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-371-75 160 in 1 BOTTLE; Type 0: Not a Combination Product 01/02/2012 2 NDC:69842-371-68 72 in 1 BOTTLE; Type 0: Not a Combination Product 12/09/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 12/09/2011 Labeler - CVS (062312574)