FDA.reportPublic FDA data

Tums Chewy Bites

Manufacturer
Haleon US Holdings LLC
Effective date
2024-08-21
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:17:38

Label at a glance#

ProductTums Chewy Bites
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 2-4 tablets as symptoms occur, or as directed by a doctor. Crush or chew 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 USP 750mg

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 6 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. Crush or chew tablets completely before swallowing.
  • 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 300mg
  • 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, beeswax, carmine, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, 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), maltodextrin, medium chain triglycerides, methylparaben, natural and artificial flavors, pharmaceutical ink, phosphoric acid, povidone, 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

Generic Section (Bottles)

SPL UNCLASSIFIED SECTION

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

Generic Section (2 ct. Pouch)

SPL UNCLASSIFIED SECTION

Safety sealed – Do not use if pouch is open or torn.

Principal Display Panel (108 ct. Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

Chewy Bites

Assorted Berries

EXTRA STRENGTH 750

108 CHEWABLE TABLETS

Tums Chewy Bites Asst Berries 108 Tablets
Tums Chewy Bites Asst Berries 108 Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN9
1044532Tums Extra Strength 750 MG (Ca 300 MG) Chewable TabletPSN9
1044532calcium carbonate 750 MG Chewable Tablet [Tums]SBD9
308915calcium carbonate 750 MG Chewable TabletSCD9
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY9
1044532Tums Chewy Bites 750 MG Chewable TabletSY9
1044532Tums E-X 750 MG (calcium 300 MG) Chewable TabletSY9
1044532Tums Kids 750 MG Chewable TabletSY9
1044532Tums Smoothies 750 MG Chewable TabletSY9

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
0135-0606-012023-03-22C16284748780-1c7ccaba7-2ad2-fd44-e053-dadaa90aa01bDrug Facts
0135-0606-022023-03-22C16284748780-1c7ccaba7-2ad2-fd44-e053-dadaa90aa01bDrug Facts
0135-0606-042023-03-22C16284748780-1c7ccaba7-2ad2-fd44-e053-dadaa90aa01bDrug Facts
0135-0606-052023-03-22C16284748780-1c7ccaba7-2ad2-fd44-e053-dadaa90aa01bDrug Facts
0135-0606-012021-07-23C16284748780-1c7ccaba7-2ad2-fd44-e053-dadaa90aa01bDrug Facts
0135-0606-022021-07-23C16284748780-1c7ccaba7-2ad2-fd44-e053-dadaa90aa01bDrug Facts
0135-0606-042021-07-23C16284748780-1c7ccaba7-2ad2-fd44-e053-dadaa90aa01bDrug Facts
0135-0606-052021-07-23C16284748780-1c7ccaba7-2ad2-fd44-e053-dadaa90aa01bDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0606-01Tums Chewy Bites32 in 1 BOTTLETABLET, CHEWABLE329
0135-0606-02Tums Chewy Bites60 in 1 BOTTLETABLET, CHEWABLE609
0135-0606-04Tums Chewy Bites8 in 1 BOTTLETABLET, CHEWABLE89
0135-0606-05Tums Chewy Bites2 in 1 PACKAGETABLET, CHEWABLE29
0135-0606-05Tums Chewy Bites54 in 1 BOTTLETABLET, CHEWABLE549
0135-0606-06Tums Chewy Bites108 in 1 BOTTLETABLET, CHEWABLE1089
0135-0606-07Tums Chewy Bites2 in 1 POUCHTABLET, CHEWABLE29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0606TUMS CHEWY BITES (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]9Current NDC, Legacy NDC, 7 package rows20240823_72ac000c-90f7-42e2-88a6-740de114a954.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0606-01EA - Each0135-0606995297c1-b4f3-4f7f-8486-7a3c87d35fe912017-04-05
0135-0606-02EA - Each0135-06067fe4edb7-f869-48c9-ba5d-c3ccbe6a29b112017-04-05
0135-0606-04EA - Each0135-060623a8dab3-4e56-44ed-b4e6-2c9f2d1131a412025-05-14

Products#

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

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-06060135-0606-01, 0135-0606-02, 0135-0606-04, 0135-0606-05, 0135-0606-06, 0135-0606-07

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
ACACIA5C5403N26OIACT
ALCOHOL3K9958V90MIACT
AMMONIA5138Q19F1XIACT
YELLOW WAX2ZA36H0S2VIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARMINIC ACIDCID8Z8N95NIACT
CARNAUBA WAXR12CBM0EIZIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCONUT OILQ9L0O73W7LIACT
STARCH, CORNO8232NY3SJIACT
CORN SYRUP9G5L16BK6NIACT
STARCH, WHEAT79QS2MG2LPIACT
ETHYL ACETATE76845O8NMZIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
FD&C BLUE NO. 2 ALUMINUM LAKE4AQJ3LG584IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
FD&C YELLOW NO. 5 ALUMINUM LAKEJQ6BLH9FR7IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
ISOPROPYL ALCOHOLND2M416302IACT
MALTODEXTRIN7CVR7L4A2DIACT
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
SOYBEANL7HT8F1ZODIACT
SOYBEAN LECITHIN1DI56QDM62IACT
SUCROSEC151H8M554IACT
TERT-BUTYLHYDROQUINONEC12674942BIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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 BitesCALCIUM CARBONATEHaleon US Holdings LLC72ac000c-90f7-42e2-88a6-740de114a9542024-08-21WarningsExact identifier
ndc (package): 0135-0606-04
ndc (package): 0135-0606-06
ndc (package): 0135-0606-02
ndc (package): 0135-0606-01
ndc (package): 0135-0606-05
ndc (package): 0135-0606-07
ndc (product): 0135-0606
ndc11 (package): 00135060606
ndc11 (package): 00135060605
ndc11 (package): 00135060602
ndc11 (package): 00135060601
ndc11 (package): 00135060604
ndc11 (package): 00135060607
spl id: 02cdd1e9-f076-4978-bd5b-a3372dbf1c34
spl set id: 72ac000c-90f7-42e2-88a6-740de114a954

Reported adverse events (FAERS/openFDA)#

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