Active Ingredient (Per Tablet)
Calcium Carbonate USP 1000mg
Leader Ultra Strength Tablet, Chewable
FDA Label NDC 70000-0459
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Leader Ultra Strength (NDC 70000-0459). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (per tablet), purpose, uses, warnings, directions, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 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.
Directions
- adults and children 12 years of age and over: chew 2-3 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 400mg
- store at room temperature. Keep container tightly closed.
Inactive Ingredients
dextrose, flavors, magnesium stearate, maltodextrin, starch, sucralose.
Questions?
1-866-467-2748
Safety sealed: Do not use if printed seal under cap is torn or missing
Package/Label Principal Display Panel
LEADER™
NDC 70000-0459-1
COMPARE TO TUMS® ULTRA STRENGTH active ingredient*
Ultra Strength
Antacid Tablets
Calcium Carbonate USP 1000mg
Peppermint Flavor
Naturally and Artificially Flavored
Relief of:
Upset stomach
Heartburn
Acid indigestion
100% Money Back Guarantee
72 CHEWABLE TABLETS
GLUTEN- FREE
© 2018 Cardinal Health. All Right Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All others marks
are the property of their respective owners.
DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
100% Money Back Guarantee
Return to place of purchase.
*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark, TUMS® Ultra Strength.
Leader Ultra Strength Antacid Chewable Tablets (103af72pvlflb)
* Please review the disclaimer below.
