Label: GOODSENSE EXTRA STRENGTH ANTACID ASSORTED FRUIT- calcium carbonate tablet, chewable
- NDC Code(s): 50804-127-22
- Packager: GoodSense
- 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 11, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (in each tablet)
- PURPOSE
- USE(S)
- WARNINGS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- IF PREGNANT OR/BREASTFEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GOODSENSE EXTRA STRENGTH ANTACID ASSORTED FRUIT
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-127 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 750 mg Inactive Ingredients Ingredient Name Strength ADIPIC ACID (UNII: 76A0JE0FKJ) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 30 (UNII: 2S42T2808B) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color ORANGE, YELLOW, GREEN, PINK (reddish pink) Score no score Shape ROUND Size 16mm Flavor CHERRY, LEMON, LIME, ORANGE Imprint Code G127 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50804-127-22 96 in 1 BOTTLE; Type 0: Not a Combination Product 08/08/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part331 08/08/2018 Labeler - GoodSense (076059836) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 MANUFACTURE(50804-127)