FDA.reportPublic FDA data

TUMS

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:09:20

Label at a glance#

ProductTUMS Smoothies
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 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
  • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains:elemental calcium 300mg
  • do not store above 25 oC (77 oF). Keep the container tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, adipic acid, calcium stearate, dextrose, FD&C red no. 40 aluminum lake, flavors, guar gum, microcrystalline cellulose, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

1-800-897-7535

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0227-01

TUMS

CALCIUM CARBONATE

ANTACID

Smoothies

Strawberry

SMOOTH DISSOLVE

EXTRA STRENGTH 750

GOES TO WORK IN SECONDS!

60CHEWABLE TABLETS

Only Available at DOLLAR GENERAL

PAREVE

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

Dist. By: GSK CH

Warren, NJ 07059

©2019 GSK or licensor.

Front Panel 1000278

1000278_Tums Smoothies Dollar General_60ct.JPG
1000278_Tums Smoothies Dollar General_60ct.JPG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN3
1044532Tums Extra Strength 750 MG (Ca 300 MG) Chewable TabletPSN3
1044532calcium carbonate 750 MG Chewable Tablet [Tums]SBD3
308915calcium carbonate 750 MG Chewable TabletSCD3
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY3
1044532Tums Chewy Bites 750 MG Chewable TabletSY3
1044532Tums E-X 750 MG (calcium 300 MG) Chewable TabletSY3
1044532Tums Kids 750 MG Chewable TabletSY3
1044532Tums Smoothies 750 MG Chewable TabletSY3

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
0135-0227-012024-03-03C16284748780-1e4f33bdf-acd6-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0227-012022-07-29C16284748780-1e4f33bdf-acd6-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0227-01TUMSSmoothies60 in 1 BOTTLETABLET, CHEWABLE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0227TUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC, 1 package rows20240304_9e54f687-4072-42fd-a14b-af67fe8b6cc4.zip

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
0135-02270135-0227-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACACIA5C5403N26OIACT
ADIPIC ACID76A0JE0FKJIACT
CALCIUM STEARATE776XM7047LIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
GUAR GUME89I1637KEIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SORBITOL506T60A25RIACT
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 SmoothiesCALCIUM CARBONATEHaleon US Holdings LLC9e54f687-4072-42fd-a14b-af67fe8b6cc42024-03-03WarningsExact identifier
ndc (package): 0135-0227-01
ndc (product): 0135-0227
ndc11 (package): 00135022701
spl id: 12c94278-9881-a2ff-e063-6394a90a8157
spl set id: 9e54f687-4072-42fd-a14b-af67fe8b6cc4

Reported adverse events (FAERS/openFDA)#

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