FDA.reportPublic FDA data

Tums

Manufacturer
Haleon US Holdings LLC
Effective date
2025-02-13
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:55:18

Label at a glance#

ProductTums Naturals
Active ingredientCALCIUM CARBONATE
Label structure12 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 2-3 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

Label contents#

Full prescribing information#

Active ingredient (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 1000 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 7 tablets in 24 hours
  • If pregnant do not take more than 5 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 2-3 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

OTHER SAFETY INFORMATION

  • each tablet contains: elemental calcium 400 mg
  • do not store above 25°C (77°F)

Inactive ingredients (Black Cherry & Watermelon)

INACTIVE INGREDIENT SECTION

calcium stearate, carmine, dextrose, flavors, gum arabic

Inactive ingredients (Coconut Pineapple)

INACTIVE INGREDIENT SECTION

calcium stearate, dextrose, flavor, gum arabic

Questions or comments?

OTC - QUESTIONS SECTION

1-800-897-7535

Generic Section

SPL UNCLASSIFIED SECTION

Do not use if printed inner safety seal under cap is broken or missing.

Gluten-Free

Non-GMO

Principal Display Panel (Black Cherry & Watermelon)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

Naturals

NOARTIFICIAL FLAVORS OR DYES

Black Cherry & Watermelon

ULTRA STRENGTH 1000

56 CHEWABLE TABLETS

Tums Naturals Black Cherry Watermelon 56 ct
Tums Naturals Black Cherry Watermelon 56 ct

Principal Display Panel (Coconut Pineapple)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

gsk

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

NEW

Naturals

NO ARTIFICIAL FLAVORS OR DYES

Coconut Pineapple

ULTRA STRENGTH 1000

56 CHEWABLE TABLETS

Tums Naturals Coconut Pineapple 56ct
Tums Naturals Coconut Pineapple 56ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308892calcium carbonate 1000 MG (Ca 400 MG) Chewable TabletPSN8
1044524Tums Ultra 1000 MG (Ca 400 MG) Chewable TabletPSN8
1044524calcium carbonate 1000 MG Chewable Tablet [Tums]SBD8
308892calcium carbonate 1000 MG Chewable TabletSCD8
308892calcium carbonate 1000 MG (calcium 400 MG) Chewable TabletSY8
1044524Tums 1000 MG Chewable TabletSY8
1044524Tums Ultra 1000 MG (calcium 400 MG) Chewable TabletSY8

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
0135-1326-012023-02-17C16284748780-1e4f33bdf-aa9f-d8a0-e053-dadaa90a6e4eDrug Facts
0135-1326-022023-02-17C16284748780-1e4f33bdf-aa9f-d8a0-e053-dadaa90a6e4eDrug Facts
0135-1326-032023-02-17C16284748780-1e4f33bdf-aa9f-d8a0-e053-dadaa90a6e4eDrug Facts
0135-1326-052023-02-17C16284748780-1e4f33bdf-aa9f-d8a0-e053-dadaa90a6e4eDrug Facts
0135-1328-012023-02-17C16284748780-1e4f33bdf-aa9f-d8a0-e053-dadaa90a6e4eDrug Facts
0135-1326-012022-07-29C16284748780-1e4f33bdf-aa9f-d8a0-e053-dadaa90a6e4eDrug Facts
0135-1326-022022-07-29C16284748780-1e4f33bdf-aa9f-d8a0-e053-dadaa90a6e4eDrug Facts
0135-1326-032022-07-29C16284748780-1e4f33bdf-aa9f-d8a0-e053-dadaa90a6e4eDrug Facts
0135-1326-052022-07-29C16284748780-1e4f33bdf-aa9f-d8a0-e053-dadaa90a6e4eDrug Facts
0135-1328-012022-07-29C16284748780-1e4f33bdf-aa9f-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-1326-01TumsNaturals56 in 1 BOTTLETABLET, CHEWABLE568
0135-1326-02TumsNaturals10 in 1 BOTTLETABLET, CHEWABLE108
0135-1326-03TumsNaturals190 in 1 BOTTLETABLET, CHEWABLE1908
0135-1326-05TumsNaturals2 in 1 POUCHTABLET, CHEWABLE28
0135-1328-01TumsNaturals56 in 1 BOTTLETABLET, CHEWABLE568

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-1326TUMS NATURALS (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 4 package rows20250215_d8da54b8-6456-4e7d-acd2-a55e2249bd01.zip
0135-1328TUMS NATURALS (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 1 package rows20250215_d8da54b8-6456-4e7d-acd2-a55e2249bd01.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-1326-01EA - Each0135-132688e49484-07a6-40d0-a5d4-280d009df33212025-06-13
0135-1326-03EA - Each0135-132642f2464a-c32e-42d9-9f3b-34a048905b5412025-06-13
0135-1328-01EA - Each0135-1328227253d3-beef-4b2e-bd05-bd7e66babbe812025-06-13

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-13260135-1326-01, 0135-1326-03, 0135-1326-02, 0135-1326-05
0135-13280135-1328-01

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
CALCIUM STEARATE776XM7047LIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
ACACIA5C5403N26OIACT
CALCIUM CARBONATEH0G9379FGKACTIB
CALCIUM STEARATE776XM7047LIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
ACACIA5C5403N26OIACT

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 NaturalsCALCIUM CARBONATEHaleon US Holdings LLCd8da54b8-6456-4e7d-acd2-a55e2249bd012025-02-13WarningsExact identifier
ndc (package): 0135-1328-01
ndc (package): 0135-1326-05
ndc (package): 0135-1326-01
ndc (package): 0135-1326-02
ndc (package): 0135-1326-03
ndc (product): 0135-1328
ndc (product): 0135-1326
ndc11 (package): 00135132601
ndc11 (package): 00135132602
ndc11 (package): 00135132603
ndc11 (package): 00135132605
ndc11 (package): 00135132801
spl id: f8025111-bc9b-4cb4-9374-eabfee016daf
spl set id: d8da54b8-6456-4e7d-acd2-a55e2249bd01

Reported adverse events (FAERS/openFDA)#

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