FDA.reportPublic FDA data

Cardinal Health Extra Strength Antacid Tablets Drug Facts

Manufacturer
CARDINAL HEALTH 110, LLC.
Effective date
2025-10-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:38:57

Label at a glance#

ProductANTACID Extra Strength
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 completely 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 a room temperature Keep this container tightly closed Safety sealed: Do not use if printed seal under cap is torn or missing.

Label contents#

Full prescribing information#

Active ingredient (in each 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

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 completely 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 a room temperature
  • Keep this container tightly closed

Safety sealed: Do not use if printed seal under cap is torn or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

adipic acid, D&C Yellow 10 Lake, dextrose, FD&C Red No.40 Lake, FD&C Yellow No 6 Lake, flavors, magnesium stearate, maltodextrin, , starch, sucralose,

Questions?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC# 70000-0682-1

COMPARE TO TUMS® EXTRA STRENGTH active ingredient*

Extra Strength

Antacid Tablets

Calcium Carbonate 750 mg

Tropical Fruit

Naturally and Artificially Flavored

Relief of:

Upset Stomach,

Heartburn, and

Acid Indigestion

100% Money Back Guarantee

96 CHEWABLE TABLETS

Distributed By: CAH

Dublin, Ohio 43017

www.myleader.com

1-800-200-6313

©2024 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal Health.

CIN 5905450

REV. 04/24

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

LEADER Extra Strength Tropical Flavor 96 Chewable Tablets
LEADER Extra Strength Tropical Flavor 96 Chewable Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN3
308915calcium carbonate 750 MG Chewable TabletSCD3
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295143560GTIN-13: 0096295143560
EAN-13: 0096295143560
GTIN-12: 096295143560
UPC-A: 096295143560
GTIN storage (14 digits): 00096295143560		ffcb6e47-62d3-4eed-9f2d-386b7ec3b5a0-01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0682-1ANTACIDExtra Strength96 in 1 BOTTLETABLET, CHEWABLE963

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0682-1EA - Each70000-0682892e6f71-4b5a-431b-8bae-e5bbf37e788412025-08-11

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
70000-068270000-0682-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
ADIPIC ACID76A0JE0FKJIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
FD&C RED NO. 40WZB9127XOAIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
CALCIUM CARBONATEH0G9379FGKACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-10-11full-release2026-06-01 00:39:20

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
ANTACID Extra StrengthCALCIUM CARBONATECARDINAL HEALTH 110, LLC.7c1b2ee6-b691-4c12-bed5-f0a360ad46bb2025-10-14WarningsExact identifier
ndc (package): 70000-0682-1
ndc (product): 70000-0682
ndc11 (package): 70000068201
spl id: 411d6747-a150-8e3d-e063-6294a90ac3db
spl set id: 7c1b2ee6-b691-4c12-bed5-f0a360ad46bb

Reported adverse events (FAERS/openFDA)#

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