FDA.reportPublic FDA data

Regular Strength Antacid Tablets Assorted Fruit Flavor

Manufacturer
CARDINAL HEALTH
Effective date
2025-10-14
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:39:00

Label at a glance#

ProductRegular Strength Antacid Assorted Fruit
Active ingredientCALCIUM CARBONATE
Label structure8 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate USP 500mg

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 aretaking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

  • do not take more than 15 tablets in 24 hours
  • if pregnant do not take more than 10 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 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

SPL UNCLASSIFIED SECTION

  • each tablets contains:elemental calcium 200mg
  • Store at room temperature. Keep the 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 Red No. 27, D&C Yellow No. 10, dextrose, FD&C Blue No. 1, flavors, magnesium stearate, maltodextrin, starch, sucralose.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70000-0034-1

COMPARE TO TUMS® REGULAR STRENGTH active ingredient*

Regular Strength

Antacid Tablets

Calcium Carbonate 500mg

Assorted Fruit Flavor

Naturally and Artificially Flavored

Relieves:

Upset Stomach

Heartburn

Acid Indigestion

100% Money Back Guarantee

150 Chewable Tablets

©2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinals Health.

All other marks are the property of their respective owners.

www.myleader.com

DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017

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

CARDINAL Regular Strength Assorted Fruit Antacid Tablets
CARDINAL Regular Strength Assorted Fruit Antacid Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSN7
308907calcium carbonate 500 MG Chewable TabletSCD7
308907calcium carbonate 500 MG (equivalent to calcium 200 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-130096295138115GTIN-13: 0096295138115
EAN-13: 0096295138115
GTIN-12: 096295138115
UPC-A: 096295138115
GTIN storage (14 digits): 00096295138115		c1171d19-5694-4e6c-9865-40c5f62c4f05-01.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
70000-0034-1Regular Strength AntacidAssorted Fruit150 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0034-1EA - Each70000-0034bc46288d-e4b6-45e9-9004-a5a236c48b6812020-01-03

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-003470000-0034-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADIPIC ACID76A0JE0FKJIACT
D&C RED NO. 272LRS185U6KIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
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 00:38:32

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
Regular Strength Antacid Assorted FruitCALCIUM CARBONATECARDINAL HEALTHdef9eaef-308f-49f2-898b-469c2c395d272025-10-14WarningsExact identifier
ndc (package): 70000-0034-1
ndc (product): 70000-0034
ndc11 (package): 70000003401
spl id: 411c1173-9548-6a79-e063-6294a90a0cdd
spl set id: def9eaef-308f-49f2-898b-469c2c395d27

Reported adverse events (FAERS/openFDA)#

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