Label: DRX CHOICE ANTACID CALCIUM REGULAR STRENGTH- calcium carbonate 500mg tablet, chewable
- NDC Code(s): 68163-101-12, 68163-101-50
- Packager: Raritan Pharmaceuticals 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 September 1, 2023
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- Active ingredient (per tablet)
- Purpose
- Uses
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Warnings
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug. Antacids may interact with certain prescription drugs.
- Directions
- Other information
- Inactive ingredients
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Principal Display Panel
DRx CHOICE®
*Compare to the active Ingredient in Regular Strength Tums®
REGULAR STRENGTH
Antacid Tablets
CALCIUM CARBONATE 500 mg
Fast Relief of Upset Stomach, Heartburn and Acid Indigestion.
Assorted Fruit
Naturally & Artificially Flavored
GLUTEN-FREE
Chewable Tablets 60
K PAREVE
DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Regular Strength Tums®.
Manufactured by: Raritan Pharmaceuticals
8 Joanna Court, East Brunswick, NJ 08816
Package label for 60ct Tablets
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
DRX CHOICE ANTACID CALCIUM REGULAR STRENGTH
calcium carbonate 500mg tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 500 mg Inactive Ingredients Ingredient Name Strength ADIPIC ACID (UNII: 76A0JE0FKJ) D&C RED NO. 27 (UNII: 2LRS185U6K) 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) STARCH, CORN (UNII: O8232NY3SJ) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color WHITE Score no score Shape ROUND Size 16mm Flavor FRUIT (assorted) Imprint Code RP101 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68163-101-12 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/17/2018 2 NDC:68163-101-50 150 in 1 BOTTLE; Type 0: Not a Combination Product 12/17/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 12/17/2018 Labeler - Raritan Pharmaceuticals Inc (127602287)