FDA.reportPublic FDA data

TUMS

Manufacturer
Haleon US Holdings LLC
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:47:23

Label at a glance#

ProductTUMS Extra Strength Sugar-Free
Active ingredientCALCIUM CARBONATE
Label structure10 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. Chew or crush tablets completely before swallowing. • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Storage and handling

• each chewable tablet contains: elemental calcium 300 mg • do not store above 25°C (77°F) • contains FD&C Yellow No. 5 (tartrazine) as a color additive

Label contents#

Full prescribing information#

Active ingredient (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 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 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. Chew or crush tablets completely before swallowing.
  • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other information

STORAGE AND HANDLING SECTION

  • each chewable tablet contains: elemental calcium 300 mg
  • do not store above 25°C (77°F)
  • contains FD&C Yellow No. 5 (tartrazine) as a color additive

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia gum, calcium stearate, FD&C red #40 alum lake, FD&C yellow #5 alum lake (tartrazine), flavors, sorbitol, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-897-7535

Additional Information

SPL UNCLASSIFIED SECTION

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

Gluten-Free

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

SUGAR-FREE

Melon Berry

80 CHEWABLE TABLETS

EXTRA STRENGTH 750

(U) PARVE

Tums SF Melon Berry ES 80 tablets
Tums SF Melon Berry ES 80 tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN5
1044532Tums Extra Strength 750 MG (Ca 300 MG) Chewable TabletPSN5
1044532calcium carbonate 750 MG Chewable Tablet [Tums]SBD5
308915calcium carbonate 750 MG Chewable TabletSCD5
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY5
1044532Tums Chewy Bites 750 MG Chewable TabletSY5
1044532Tums E-X 750 MG (calcium 300 MG) Chewable TabletSY5
1044532Tums Kids 750 MG Chewable TabletSY5
1044532Tums Smoothies 750 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0155-012022-12-19C16284748780-1e4f33bdf-ae6d-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0155-012022-07-29C16284748780-1e4f33bdf-ae6d-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0155-01TUMSExtra Strength Sugar-Free80 in 1 BOTTLETABLET, CHEWABLE805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0155TUMS EXTRA STRENGTH SUGAR-FREE (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]5Current NDC, Legacy NDC, 1 package rows20241222_3495102f-55d2-4a94-8d55-f46f49e00c27.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0155-01EA - Each0135-01555f57329f-0e9e-4e55-a98b-c2fb4f07034a12018-04-19

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
0135-01550135-0155-01

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
CALCIUM CARBONATEH0G9379FGKACTIB
ACACIA5C5403N26OIACT
CALCIUM STEARATE776XM7047LIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5 ALUMINUM LAKEJQ6BLH9FR7IACT
ALUMINUM OXIDELMI26O6933IACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

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 Extra Strength Sugar-FreeCALCIUM CARBONATEHaleon US Holdings LLC3495102f-55d2-4a94-8d55-f46f49e00c272024-12-19WarningsExact identifier
ndc (package): 0135-0155-01
ndc (product): 0135-0155
ndc11 (package): 00135015501
spl id: 9f61f1b5-7d7e-401a-b515-0d5b4e7360db
spl set id: 3495102f-55d2-4a94-8d55-f46f49e00c27

Reported adverse events (FAERS/openFDA)#

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