Label: EXTRA STRENGTH SMOOTH ANTACID- calcium carbonate tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 71713-204-03 - Packager: Thirty Madison 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 January 6, 2022
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- Download DRUG LABEL INFO: PDF XML
- 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 BREAST FEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
EXTRA STRENGTH SMOOTH ANTACID
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71713-204 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) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) SORBITOL (UNII: 506T60A25R) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color RED (light red) , BLUE (light blue) , PINK (light pink) Score no score Shape ROUND Size 16mm Flavor BERRY (STRAWBERRY, RASPBERRY, WIDBERRY) , CHERRY Imprint Code G173 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71713-204-03 60 in 1 BOTTLE; Type 0: Not a Combination Product 05/17/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part331 05/17/2019 Labeler - Thirty Madison Inc (080774087)