Active Ingredient (Per Tablet)
Calcium Carbonate USP 750 mg
Leader Extra Strength Sugar Free Antacid Tablet, Chewable
FDA Label NDC 70000-0460
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 Extra Strength Sugar Free Antacid (NDC 70000-0460). 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 or comments?, 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 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 at room temperature. Keep the container tightly closed.
Inactive Ingredients
adipic acid, FD&C Yellow No. 6, flavors, magnesium stearate, maltodextrin, sorbitol, 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
NDC 70000-0460-1
LEADER™
COMPARE TO TUMS® EXTRA STRENGTH active ingredient *
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SUGAR-FREE
EXTRA STRENGTH
Antacid
Tablets
Calcium Carbonate USP 750 mg
90 CHEWABLE TABLETS
© 2018 Cardinal Health.
All Rights Reserved.
CARDINAL HEALTH, the Cardinal Health LOGO, LEADER and the Leader LOGO are the trademarks or registered trademarks of Cardinal Health.
All other marks are the property of their respective owners.
1-800-200-6313
DISTRIBUTED BY: CARDINAL HEALTH
DUBLIN, OHIO 43017
*This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, TUMS® Extra Strength.
Leader Extra Strength Sugar Free Antacid Tablets Orange Cream Flavor (102ab96pvlflb)
* Please review the disclaimer below.
