FDA.reportPublic FDA data

Tums

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:09:20

Label at a glance#

ProductTums Regular Strength
Active ingredientCALCIUM CARBONATE
Label structure9 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 500mg

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 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 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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Click here to enter Precautions

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 chewable tablet contains:elemental calcium 200 mg
  • do not store above 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, dextrose, flavor, maltodextrin, mineral oil, polyethylene glycol, talc

Questions?

OTC - QUESTIONS SECTION

1-800-897-7535

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0611-01

TUMS ®

ANTACID

CALCIUM CARBONATE

GOES TO WORK IN SECONDS!

Mint

REGULARE STRENGTH 500

150 CHEWABLE TABLETS

PAREVE

Safety sealed – Do not use if printed inner seal beneath cap is missing or broken.

Trademarks are owned by or licensed to the GSK group of companies.

Dist. by:

GSKConsumer Healthcare

Warren, NJ 07059

©2014 GSK or its licensor

Front Label: 105436XA

Back Label: 105437XA

Tums Regular Mint 150 ct front label
Tums Regular Mint 150 ct front label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSN5
210117Tums 500 MG (Ca 200 MG) Chewable TabletPSN5
210117calcium carbonate 500 MG Chewable Tablet [Tums]SBD5
308907calcium carbonate 500 MG Chewable TabletSCD5
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSY5
210117Tums 500 MG (as calcium 200 MG) Chewable TabletSY5
210117Tums Freshers 500 MG Chewable TabletSY5

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
0135-0611-01TumsRegular Strength150 in 1 BOTTLETABLET, CHEWABLE1505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0611TUMS REGULAR STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]5Current NDC, Legacy NDC, 1 package rows20240304_ac80f627-3f51-425b-8c75-e07363048b00.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0611-01EA - Each0135-06114fc85997-5c94-4a42-bf46-e1566f8ac6c412017-09-11

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-06110135-0611-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POWDERED CELLULOSESMD1X3XO9MIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MALTODEXTRIN7CVR7L4A2DIACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TALC7SEV7J4R1UIACT
CALCIUM CARBONATEH0G9379FGKACTIB

Source Document#

Source XML

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
Tums Regular StrengthCALCIUM CARBONATEHaleon US Holdings LLCac80f627-3f51-425b-8c75-e07363048b002024-03-03WarningsExact identifier
ndc (package): 0135-0611-01
ndc (product): 0135-0611
ndc11 (package): 00135061101
spl id: 12c98e11-49eb-b55e-e063-6394a90ae122
spl set id: ac80f627-3f51-425b-8c75-e07363048b00

Reported adverse events (FAERS/openFDA)#

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