FDA Label for Extra Strength Sugar Free Orange Cream Flavor

View Indications, Usage & Precautions

Extra Strength Sugar Free Orange Cream Flavor Product Label

The following document was submitted to the FDA by the labeler of this product Raritan Pharmaceuticals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (Per Tablet)



Calcium Carbonate USP 750 mg


Purpose



Antacid


Uses



relieves

  • •heartburn
  • •acid indigestion
  • •sour stomach
  • •upset stomach associated with these symptoms

Warnings



Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

  • •do not take more than 9 tablets in 24 hours
  • •If pregnant do not take more than 6 tablets in 24 hours
  • •do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Directions



  • adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur ,or as directed by a doctor
  • •do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other Information



  • •each tablet contains: elemental calcium 300 mg
  • •store below 30°C (86°F).

Inactive Ingredients



adipic acid, flavors, magnesium stearate, maltodextrin, sorbitol, starch, sucralose, FD&C Yellow No. 6 lake.


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



NDC 68163-202-90

DRxCHOICE®

COMPARE TO TUMS® active ingredient*

EXTRA STRENGTH

Antacid

Tablets

Calcium Carbonate USP 750 mg

Sugar-Free

  •  Relieves:
    • •Acid Indigestion
    • •Sour Stomach
    • •Heartburn
    •  Orange Cream Flavor
    •  Naturally and Artificially Flavored
    •  GLUTEN FREE
    • 90 CHEWABLE TABLETS

      K PARVE

      Distributed by:

      Raritan Pharmaceuticals

      8 Joanna Court, East Brunswick, NJ 08816

      *This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, TUMS®.


* Please review the disclaimer below.