FDA.reportPublic FDA data

LEADER Extra Strength Antacid Tablets Wintergreen Flavor Drug Facts

Manufacturer
CARDINAL HEALTH
Effective date
2025-10-14
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:38:56

Label at a glance#

ProductCardinalExtra Strength Antacid Wintergreen flavor
Active ingredientCALCIUM CARBONATE
Label structure9 sections

Indications and uses

relieves heartburn sour stomach acid indigestion 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 swallow tablets whole. do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Storage and handling

each tablet contains : calcium 300mg store at room temperature. Keep the container tightly closed DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Label contents#

Full prescribing information#

Active ingredient (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate USP 750mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves

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

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

OTC - WHEN USING SECTION

  • do not take more than 10 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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 swallow tablets whole.
  • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 300mg
  • store at room temperature. Keep the container tightly closed

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Yellow No. 10, dextrose, FD&C Blue No. 1, flavor, magnesium stearate, maltodextrin, starch, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 70000-0592-1

Compare to the active ingredient in Extra Strength Tums®

EXTRA STRENGTH

Antacid Tablets

Calcium Carbonate 750 mg

Fast Relief of Upset Stomach, Heartburn, and Acid Indigestion

Wintergreen

Naturally and Artificially Flavored

96 Chewable Tablets

GLUTEN FREE

K PAREVE

Distributed By

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

LDR Extra Strength Calicium Carbonate 96 chewable Tablets
LDR Extra Strength Calicium Carbonate 96 chewable Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN6
308915calcium carbonate 750 MG Chewable TabletSCD6
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY6

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
70000-0592-1CardinalExtra StrengthAntacid Wintergreen flavor96 in 1 BOTTLETABLET, CHEWABLE966

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0592-1EA - Each70000-059267d9c725-d234-4176-9631-927d1a2cd83f12022-07-06

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-059270000-0592-1

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
D&C YELLOW NO. 1035SW5USQ3GIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
CALCIUM CARBONATEH0G9379FGKACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-11-21full-release2026-06-01 00:38:19

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
CardinalExtra Strength Antacid Wintergreen flavorCALCIUM CARBONATECARDINAL HEALTH4e40989f-c710-442a-bb8d-02e813ddf04d2025-10-14WarningsExact identifier
ndc (package): 70000-0592-1
ndc (product): 70000-0592
ndc11 (package): 70000059201
spl id: 411c0c6e-500d-dc88-e063-6294a90a3345
spl set id: 4e40989f-c710-442a-bb8d-02e813ddf04d

Reported adverse events (FAERS/openFDA)#

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