FDA.reportPublic FDA data

Tums Chewy Bites with Gas Relief - Haleon US Holdings LLC

Manufacturer
Haleon US Holdings LLC
Effective date
2026-06-09
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-06-11 05:11:23

Label at a glance#

ProductTums Chewy Bites with Gas Relief
Active ingredientCALCIUM CARBONATE, DIMETHICONE, UNSPECIFIED
Label structure9 sections

Indications and uses

relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms gas associated with heartburn, sour stomach, or acid indigestion

Dosage and administration

adults and children 12 years of age and over: chew 1-2 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 ingredients (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate USP 750 mg

Simethicone USP 80 mg

Purposes

OTC - PURPOSE SECTION

Antacid

Antigas

Uses

INDICATIONS & USAGE SECTION

relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms
  • gas associated with heartburn, sour stomach, or acid indigestion

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 1-2 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)
  • 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 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, propylene glycol, propylparaben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, vegetable oil

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-452-0051

Additional Information

SPL UNCLASSIFIED SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAST RELIEF OF HEARTBURN& GAS

CALCIUM CARBONATE / SIMETHICONE

TUMS with Gas Relief

ANTACID/ANTIGAS

Chewy Bites

Relieves:

  • Heartburn
  • Acid Indigestion
  • Upset Stomach
  • Bloating and Gas

Lemon & Strawberry

54 CHEWABLE TABLETS

Tums Chewy Bites Gas Relief 54 ct
Tums Chewy Bites Gas Relief 54 ct

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0624-01EA - Each0135-0624aa4f22b6-66f9-470b-9b16-14469b87d76012018-04-19
0135-0624-02EA - Each0135-06244bced855-2d7b-42df-844c-52575521b25512024-04-05

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-06240135-0624-01, 0135-0624-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 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 RED NO. 40WZB9127XOAIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
FD&C YELLOW NO. 5 ALUMINUM LAKEJQ6BLH9FR7IACT
MALTODEXTRIN7CVR7L4A2DIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
METHYLPARABENA2I8C7HI9TIACT
PHOSPHORIC ACIDE4GA8884NNIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SHELLAC46N107B71OIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBIC ACIDX045WJ989BIACT
SOYBEAN LECITHIN1DI56QDM62IACT
SUCROSEC151H8M554IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CORN OIL8470G57WFMIACT
CALCIUM CARBONATEH0G9379FGKACTIB
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-07-08full-release2026-06-01 01:06:47

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 with Gas ReliefCALCIUM CARBONATE AND SIMETHICONEHaleon US Holdings LLC6d7be7e4-4bff-4cfd-bbbe-df412ac9db102026-06-09WarningsExact identifier
ndc (package): 0135-0624-01
ndc (package): 0135-0624-02
ndc (product): 0135-0624
ndc11 (package): 00135062402
ndc11 (package): 00135062401
spl id: 53d4d4d4-351c-509f-e063-6394a90afbce
spl set id: 6d7be7e4-4bff-4cfd-bbbe-df412ac9db10

Reported adverse events (FAERS/openFDA)#

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