FDA.reportPublic FDA data

TUMS

Manufacturer
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Effective date
2020-12-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:03:01

Label at a glance#

ProductTUMS ULTRA
Active ingredientCALCIUM CARBONATE
Label structure11 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 • 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 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
  • 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 400mg
  • do not store below 25oC (77oF)

 

Inactive ingredients (Tropical Fruit)

INACTIVE INGREDIENT SECTION

cellulose, dextrose, FD&C red #40 alum lake, FD&C yellow #5 alum lake (tartrazine), FD&C yellow #6 alum lake, flavor, maltodextrin, mineral oil, polyethylene glycol, talc

Inactive ingredient (Mint)

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 0135-0610-01

TUMS®

CALCIUM CARBONATE

ANTACID

GOES TO WORK IN SECONDS!

TROPICAL FRUIT

ULTRA STRENGTH 1000

72 CHEWABLE TABLETS

©2014 GSK

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:

GSK Consumer Healthcare

Warren, NJ 07059

©2014 GSK or its licensor

105439XA (Front Label)

105440XA (Back Label)

Tums Ultra Tropical Fruit 72 count front label
Tums Ultra Tropical Fruit 72 count front label

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0612-01

TUMS®

CALCIUM CARBONATE

ANTACID

GOES TO WORK IN SECONDS!

MINT

ULTRA STRENGTH 1000

72 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:

GSK Consumer Healthcare

Warren, NJ 07059

©2014 GSK or its licensor

105430XA (Front Label)

105431XA (Back Label)

Tums Ultra Mint 72 count front label
Tums Ultra Mint 72 count front label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0610-012024-04-04C16284748780-11030e364-fb6b-111a-e063-dadaa90a10e2Drug Facts
0135-0610-022024-04-04C16284748780-11030e364-fb6b-111a-e063-dadaa90a10e2Drug Facts
0135-0612-012024-04-04C16284748780-11030e364-fb6b-111a-e063-dadaa90a10e2Drug Facts
0135-0612-022024-04-04C16284748780-11030e364-fb6b-111a-e063-dadaa90a10e2Drug Facts
0135-0610-012024-01-30C16284748780-11030e364-fb6b-111a-e063-dadaa90a10e2Drug Facts
0135-0610-022024-01-30C16284748780-11030e364-fb6b-111a-e063-dadaa90a10e2Drug Facts
0135-0612-012024-01-30C16284748780-11030e364-fb6b-111a-e063-dadaa90a10e2Drug Facts
0135-0612-022024-01-30C16284748780-11030e364-fb6b-111a-e063-dadaa90a10e2Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0612-01EA - Each0135-061206a4f08d-5510-4a10-890b-bc24a3cbe99f12017-03-06
0135-0612-02EA - Each0135-06120a5c788e-ecac-4e18-a9a5-c221f56e370412017-03-06

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-06100135-0610-01, 0135-0610-02
0135-06120135-0612-01, 0135-0612-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
POWDERED CELLULOSESMD1X3XO9MIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
ALUMINUM OXIDELMI26O6933IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MALTODEXTRIN7CVR7L4A2DIACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TALC7SEV7J4R1UIACT
CALCIUM CARBONATEH0G9379FGKACTIB
POWDERED CELLULOSESMD1X3XO9MIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MALTODEXTRIN7CVR7L4A2DIACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TALC7SEV7J4R1UIACT

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
15501612-aea8-f4a0-e063-6294a90acde7ee3faeab-4cea-4852-9ddf-901a346c092a2024-04-04WarningsExact identifier
spl set id: ee3faeab-4cea-4852-9ddf-901a346c092a

Reported adverse events (FAERS/openFDA)#

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