FDA Label for Leader Ultra Strength Antacid

View Indications, Usage & Precautions

Leader Ultra Strength Antacid Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. 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 (In Each Tablet)



Calcium carbonate 1000 mg


Purpose



Antacid


Use(S)



relieves:

  • acid indigestion
  • heartburn

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 7 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.


If Pregnant Or/Breastfeeding,



ask a health professional before use.


Keep Out Of Reach Of Children



.


Directions



  • adults and children 12 years of age and over: chew 2-3 tablets as symptoms occur, or as directed by a doctor.

Other Information



  • each tablet contains: elemental calcium 400 mg
  • do not use if printed seal under the cap is torn or missing
  • store at room temperature. keep the container tightly closed.

Inactive Ingredients



adipic acid, corn starch, crospovidone, dextrose, FD&C blue 1 lake, FD&C red 40 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.


Principal Display Panel



LEADER
NDC 70000-0436-1
Ultra Strength
Antacid
Tablets

Calcium Carbonate 1000 mg
Assorted Berry Flavor

Relief of:
Heartburn and
Acid Indigestion 

COMPARE TO TUMS® ULTRA STRENGTH active ingredient*

72 CHEWABLE TABLETS




* Please review the disclaimer below.