FDA.reportPublic FDA data

Tums Chewy Bites

Manufacturer
Haleon US Holdings LLC
Effective date
2025-02-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:55:19

Label at a glance#

ProductTums Chewy Bites Orange and Cream ES
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. 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 chewable tablet contains: elemental calcium 300 mg
  • do not store above 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, beeswax, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, FD&C yellow no. 6, FD&C yellow no. 6 aluminum lake, maltodextrin, methylparaben, natural and artificial flavors, pharmaceutical ink, phosphoric acid, propylene glycol, propylparaben, purified water, shellac, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, vegetable oil

Questions or comments?

OTC - QUESTIONS SECTION

1-800-452-0051

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

Chewy Bites

ORANGE & CREAM

EXTRA STRENGTH 750

60 CHEWABLE TABLETS

Tums CB Orange and Cream 60 ct
Tums CB Orange and Cream 60 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN4
1044532Tums Extra Strength 750 MG (Ca 300 MG) Chewable TabletPSN4
1044532calcium carbonate 750 MG Chewable Tablet [Tums]SBD4
308915calcium carbonate 750 MG Chewable TabletSCD4
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY4
1044532Tums Chewy Bites 750 MG Chewable TabletSY4
1044532Tums E-X 750 MG (calcium 300 MG) Chewable TabletSY4
1044532Tums Kids 750 MG Chewable TabletSY4
1044532Tums Smoothies 750 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
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
0135-0642-01Tums Chewy BitesOrange and Cream ES1 in 1 CARTONTABLET, CHEWABLE14
0135-0642-01Tums Chewy BitesOrange and Cream ES32 in 1 BOTTLETABLET, CHEWABLE324

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0642TUMS CHEWY BITES ORANGE AND CREAM ES (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 2 package rows20250216_036ef1ed-32ef-46b8-8817-b3f63a014280.zip

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
0135-06420135-0642-01

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
CALCIUM CARBONATEH0G9379FGKACTIB
ACACIA5C5403N26OIACT
YELLOW WAX2ZA36H0S2VIACT
CARNAUBA WAXR12CBM0EIZIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCONUT OILQ9L0O73W7LIACT
STARCH, CORNO8232NY3SJIACT
CORN SYRUP9G5L16BK6NIACT
DEXTRIN, CORNVAD2K35XAJIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
MALTODEXTRIN7CVR7L4A2DIACT
METHYLPARABENA2I8C7HI9TIACT
PHOSPHORIC ACIDE4GA8884NNIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SHELLAC46N107B71OIACT
SORBIC ACIDX045WJ989BIACT
SORBITOL506T60A25RIACT
SOYBEAN LECITHIN1DI56QDM62IACT
SUCROSEC151H8M554IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CORN OIL8470G57WFMIACT

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 Orange and Cream ESCALCIUM CARBONATEHaleon US Holdings LLC036ef1ed-32ef-46b8-8817-b3f63a0142802025-02-14WarningsExact identifier
ndc (package): 0135-0642-01
ndc (product): 0135-0642
ndc11 (package): 00135064201
spl id: ce65b4cc-cb90-4d8e-8831-158b60176bdb
spl set id: 036ef1ed-32ef-46b8-8817-b3f63a014280

Reported adverse events (FAERS/openFDA)#

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