Label: ULTRA STRENGTH ANTACID- calcium carbonate tablet, chewable
-
Contains inactivated NDC Code(s)
NDC Code(s): 68163-316-16, 68163-316-72 - 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 January 18, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (per tablet)
- Purpose
- Uses
-
Warnings
Ask a doctor or pharmacist before use if you are presentlytaking a prescription drug. Antacids may interact with certain prescription drugs.
When using this product
- •
- do not take more than 7 tablets in 24 hours
- •
- if pregnant do not take more than 5 tablets in 24 hours
- •
- do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
-
Package/Label Principal Display Panel
DRx CHOICE
Compare to the active ingredient in Ultra Strength TUMS®
ULTRA STRENGTH
Antacid Tablets
Calcium Carbonate 1000mg
Fast Relief of Upset stomach, Heartburn and Acid Indigestion
Assorted Fruit
Naturally &Artificially Flavored
GLUTEN-FREE
††This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Ultra Strength Tums®
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court
East Brunswick, NJ 08816
Package label for 160 Chewable Tablets
-
INGREDIENTS AND APPEARANCE
ULTRA STRENGTH ANTACID
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-316 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 1000 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 RED, YELLOW, ORANGE, GREEN Score no score Shape ROUND Size 19mm Flavor FRUIT (Assorted) Imprint Code RP103 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68163-316-16 160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/04/2021 2 NDC:68163-316-72 72 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/04/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 01/04/2021 Labeler - Raritan Pharmaceuticals Inc (127602287)