ULTRA STRENGTH ANTACID- calcium carbonate tablet, chewable 
Raritan Pharmaceuticals Inc

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.

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DRx Choice Antacid Tablets 1000 Calcium Carbonate 1000 mg Ultra Strength Assorted fruits Flavor 160 Chewable Tablets

Active ingredient (per tablet)

Calcium Carbonate USP 1000 mg

Purpose

Antacid

Uses

relieves

• heartburn

• sour stomach

• acid indigestion

• upset stomach associated with these symptoms

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

adults and children 12 years of age and over: chew 2-3 tablets completely as symptoms occur, or as directed by a doctor. Do not swallow tablets as whole.
do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other information

each tablet contains: calcium 400 mg
store at room temperature. Keep the container tightly closed

Inactive ingredients

adipic acid, D&C red No. 27 Lake, D&C yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C yellow No. 6 Lake, flavors, magnesium stearate, maltodextrin, , starch, sucralose.

Questions or comments?

1-866-467-2748

Safety sealed: Do not use if printed seal under cap is torn or missing

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

DRx Choice Ultra Strength Antacid 160 Chewable Tablets

Package Label for 72 Chewable Tablets

DRx Choice Ultra Strength Antacid 72 Chewable Tablets
ULTRA STRENGTH ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-316
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorRED, YELLOW, ORANGE, GREENScoreno score
ShapeROUNDSize19mm
FlavorFRUIT (Assorted) Imprint Code RP103
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68163-316-16160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/04/2021
2NDC:68163-316-7272 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/04/2021
Labeler - Raritan Pharmaceuticals Inc (127602287)

Revised: 1/2021
Document Id: 5feadecf-5b7c-423e-a9de-ee226c3734a8
Set id: 5feadecf-5b7c-423e-a9de-ee226c3734a8
Version: 1
Effective Time: 20210118
 
Raritan Pharmaceuticals Inc