FDA.reportPublic FDA data

Tums Chewy Bites

Manufacturer
Haleon US Holdings LLC
Effective date
2025-11-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:17:03

Label at a glance#

ProductTums Chewy Bites Vanilla and Mint
Active ingredientCALCIUM CARBONATE
Label structure10 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. 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 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 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. 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

SPL UNCLASSIFIED SECTION

  • each tablet contains:elemental calcium 300 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

acacia, beeswax, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, FD&C blue no. 1 aluminum lake, FD&C yellow no. 5 aluminum lake (tartrazine), maltodextrin, monoammoniated glycyrrhizin, natural and artificial flavors, pharmaceutical ink, polyvinylpyrrolidone, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, vegetable oil

Questions or comments?

OTC - QUESTIONS SECTION

1-800-452-0051

Additional Information

SPL UNCLASSIFIED SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEWLIMITED EDITION

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

Chewy Bites

Vanilla & Mint

EXTRA STRENGTH 750

60CHEWABLE TABLETS

Tums Chewy Bites Vanilla and Mint 60 ct
Tums Chewy Bites Vanilla and Mint 60 ct

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 Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-5970-60TumsChewy Bites Vanilla and Mint60 in 1 BOTTLETABLET, CHEWABLE603

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-59700135-5970-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACACIA5C5403N26OIACT
YELLOW WAX2ZA36H0S2VIACT
CARNAUBA WAXR12CBM0EIZIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCONUT OILQ9L0O73W7LIACT
STARCH, CORNO8232NY3SJIACT
CORN SYRUP9G5L16BK6NIACT
DEXTRIN, CORNVAD2K35XAJIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
FD&C YELLOW NO. 5 ALUMINUM LAKEJQ6BLH9FR7IACT
MALTODEXTRIN7CVR7L4A2DIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
COPOVIDONE K25-31D9C330MD8BIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SHELLAC46N107B71OIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBIC ACIDX045WJ989BIACT
SORBITOL506T60A25RIACT
SOYBEAN LECITHIN1DI56QDM62IACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CANOLA OIL331KBJ17RKIACT
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 Chewy Bites Vanilla and MintCALCIUM CARBONATEHaleon US Holdings LLC2b9dd909-c850-3c21-e063-6394a90a15a82025-11-19WarningsExact identifier
ndc (package): 0135-5970-60
ndc (product): 0135-5970
ndc11 (package): 00135597060
spl id: 43f45bd8-7ba4-057c-e063-6294a90a0077
spl set id: 2b9dd909-c850-3c21-e063-6394a90a15a8

Reported adverse events (FAERS/openFDA)#

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