FDA.reportPublic FDA data

Leader Health Extra Strength SUGAR FREE Antacid Tablets Calcium Carbonate 750 mg

Manufacturer
Cardinal Health
Effective date
2025-10-14
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:38:59

Label at a glance#

ProductLeader Extra Strength Sugar Free Antacid
Active ingredientCALCIUM CARBONATE
Label structure8 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate USP 750 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves

• heartburn

• acid indigestion

• sour stomach

• upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist before use if you arepresently 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

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

• each tablet contains: elemental calcium 300 mg

• store at room temperature. Keep the container tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

SAFETY SEALED: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70000-0460-1

LEADER ™

COMPARE TO TUMS® EXTRA STRENGTH active ingredient *

100% Money Back Guarantee

SUGAR-FREE

EXTRA STRENGTH

Antacid

Tablets

Calcium Carbonate USP 750 mg

  • Orange Cream Flavor
  • Naturally and Artificially Flavored
  • GLUTEN FREE
  • Relief of:
  • Upset Stomach, Heartburn, and Acid Indigestion

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.

www.myleader.com

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
Leader Extra Strength Sugar Free Antacid Tablets Orange Cream Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN7
308915calcium carbonate 750 MG Chewable TabletSCD7
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295136425GTIN-13: 0096295136425
EAN-13: 0096295136425
GTIN-12: 096295136425
UPC-A: 096295136425
GTIN storage (14 digits): 00096295136425		102AB96PVLFLB.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0460-1Leader Extra Strength Sugar Free Antacid90 in 1 BOTTLE, PLASTICTABLET, CHEWABLE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0460-1EA - Each70000-046081eae8d1-5dd3-46e8-b75b-5b5935b3cbfd12019-08-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-046070000-0460-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADIPIC ACID76A0JE0FKJIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SORBITOL506T60A25RIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
CALCIUM CARBONATEH0G9379FGKACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-11-21full-release2026-06-01 00:38:31

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Extra Strength Sugar Free AntacidANTACIDCardinal Healthd7a6f1b8-bdf7-45bb-bab0-b22f45e784402025-10-14WarningsExact identifier
ndc (package): 70000-0460-1
ndc (product): 70000-0460
ndc11 (package): 70000046001
spl id: 411c182e-9152-6b6f-e063-6394a90a4a86
spl set id: d7a6f1b8-bdf7-45bb-bab0-b22f45e78440

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.