FDA.reportPublic FDA data

Tums Chewy Bites

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:09:20

Label at a glance#

ProductTums Chewy Bites Mixed Fruit
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. 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

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 1000mg

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 4 tablets in 24 hours
  • if pregnant do not take more than 4 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 (54 ct. Bottle)

SPL UNCLASSIFIED SECTION

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

Other information (200 ct. Bottle)

SPL UNCLASSIFIED SECTION

  • each chewable tablet contains:elemental calcium 400 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

alcohol, ammonium hydroxide, beeswax, carmine, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C blue no.2 aluminum lake, FD&C red no.40, FD&C red no.40 aluminum lake, FD&C yellow no.5 aluminum lake (tartrazine), FD&C yellow no.6, FD&C yellow no.6 aluminum lake, flavors, gum arabic, isopropyl alcohol, maltodextrin, medium-chain triglycerides, methylparaben, modified starch, n-butyl alcohol, phosphoric acid, polyvinylpyrrolidone, propylene glycol, propylparaben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, triacetin, vegetable oil

Questions or comments?

OTC - QUESTIONS SECTION

1-800-897-7535

Principal Display Panel (54 ct. Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0641-03

TUMS

CALCIUM CARBONATE

ANTACID

Chewy Bites

Mixed Fruit

ULTRA STRENGTH 1000

GOES TO WORK IN SECONDS!

54 CHEWABLE TABLETS

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

Distributed by:

GSKConsumer Healthcare

Warren, NJ 07059

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

©2020 GSK group of companies or its licensor

Front Label: 1000870

Back Label: 1000871

1000870_TUMS_CB_MB_CHEWABLE_54_CT_LABEL
1000870_TUMS_CB_MB_CHEWABLE_54_CT_LABEL

Principal Display Panel (200 ct. Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Great Value, New Look!

NDC 0135-0183-03

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

Chewy Bites

Mixed Fruit

Ultra Strength 1000

200 CHEWABLE TABLETS

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

Distributed by: GSK Consumer Healthcare,Warren, NJ 07059

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

©2022 GSK group of companies or its licensor.

Tums Chewy Bites Ultra Mixed Fruit 200 ct
Tums Chewy Bites Ultra Mixed Fruit 200 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308892calcium carbonate 1000 MG (Ca 400 MG) Chewable TabletPSN4
1044524Tums Ultra 1000 MG (Ca 400 MG) Chewable TabletPSN4
1044524calcium carbonate 1000 MG Chewable Tablet [Tums]SBD4
308892calcium carbonate 1000 MG Chewable TabletSCD4
308892calcium carbonate 1000 MG (calcium 400 MG) Chewable TabletSY4
1044524Tums 1000 MG Chewable TabletSY4
1044524Tums Ultra 1000 MG (calcium 400 MG) Chewable TabletSY4

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
0135-0138-03Tums Chewy BitesMixed Fruit200 in 1 BOTTLETABLET, CHEWABLE2004
0135-0641-03Tums Chewy BitesMixed Fruit54 in 1 BOTTLETABLET, CHEWABLE544
0135-0641-03Tums Chewy BitesMixed Fruit3 in 1 PACKAGETABLET, CHEWABLE34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0138TUMS CHEWY BITES MIXED FRUIT (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]4Current NDC, 1 package rows20240304_d341b832-edcf-4cb2-96e1-c303b030c59a.zip
0135-0641TUMS CHEWY BITES MIXED FRUIT (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 2 package rows20240304_d341b832-edcf-4cb2-96e1-c303b030c59a.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-06410135-0641-03
0135-01380135-0138-03

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 78 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
AMMONIA5138Q19F1XIACT
YELLOW WAX2ZA36H0S2VIACT
CARMINIC ACIDCID8Z8N95NIACT
CARNAUBA WAXR12CBM0EIZIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCONUT OILQ9L0O73W7LIACT
STARCH, CORNO8232NY3SJIACT
CORN SYRUP9G5L16BK6NIACT
ICODEXTRIN2NX48Z0A9GIACT
ETHYL ACETATE76845O8NMZIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALUMINUM OXIDELMI26O6933IACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ACACIA5C5403N26OIACT
ISOPROPYL ALCOHOLND2M416302IACT
MALTODEXTRIN7CVR7L4A2DIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
METHYLPARABENA2I8C7HI9TIACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TIACT
BUTYL ALCOHOL8PJ61P6TS3IACT
PHOSPHORIC ACIDE4GA8884NNIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SHELLAC46N107B71OIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBIC ACIDX045WJ989BIACT
SORBITOL506T60A25RIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SUCROSEC151H8M554IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
CORN OIL8470G57WFMIACT
CALCIUM CARBONATEH0G9379FGKACTIB
ALCOHOL3K9958V90MIACT

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 Chewy Bites Mixed FruitCALCIUM CARBONATEHaleon US Holdings LLCd341b832-edcf-4cb2-96e1-c303b030c59a2024-03-02WarningsExact identifier
ndc (package): 0135-0138-03
ndc (package): 0135-0641-03
ndc (product): 0135-0641
ndc (product): 0135-0138
ndc11 (package): 00135064103
ndc11 (package): 00135013803
spl id: 12b447a1-1d24-383f-e063-6394a90affdd
spl set id: d341b832-edcf-4cb2-96e1-c303b030c59a

Reported adverse events (FAERS/openFDA)#

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