FDA.reportPublic FDA data

Tums Antacid Chewy Bites

Manufacturer
R J General Corporation
Effective date
2025-11-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:16:29

Label at a glance#

ProductTums Antacid Chewy Bites
Active ingredientCALCIUM CARBONATE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

​Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)Purpose
Calcium Carbonate USP 750mgAntacid

INDICATIONS & USAGE SECTION

Uses
relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug. Antacids may interact with certain prescription drugs.

OTC - WHEN USING SECTION

When using this product

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years of age and over:chew 2-4 tablets as symptoms occur, or as directed by a doctor
  • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

SPL UNCLASSIFIED SECTION

Other information

  • 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 INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions or comments?
1-800-897-7535

Dist. by:

Haleon,Warren, NJ 07059

Packaged and distributed by RJ Corp with the permission of HALEON

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calcium Carbonate Tums Antacid Chewy Bites Assorted Berries - NDC 70264-046-01 - 50 Chewable Tablets Carton Label

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN2
1044532Tums Extra Strength 750 MG (Ca 300 MG) Chewable TabletPSN2
1044532calcium carbonate 750 MG Chewable Tablet [Tums]SBD2
308915calcium carbonate 750 MG Chewable TabletSCD2
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY2
1044532Tums Chewy Bites 750 MG Chewable TabletSY2
1044532Tums E-X 750 MG (calcium 300 MG) Chewable TabletSY2
1044532Tums Kids 750 MG Chewable TabletSY2
1044532Tums Smoothies 750 MG Chewable TabletSY2

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
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
70264-046-01Tums Antacid Chewy Bites2 in 1 POUCHTABLET22
70264-046-01Tums Antacid Chewy Bites25 in 1 CARTONTABLET252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-1000-01EA - Each0135-1000974813a5-101e-4401-89d7-fc7bb3f4ad4b12025-06-13

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70264-04670264-046-01
0135-1000

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACACIA5C5403N26OIACT
BEESWAX2ZA36H0S2VIACT
CARMINIC ACIDCID8Z8N95NIACT
CARNAUBA WAXR12CBM0EIZIACT
CITRIC ACID2968PHW8QPIACT
COCONUT OILQ9L0O73W7LIACT
STARCH, CORNO8232NY3SJIACT
CORN SYRUP9G5L16BK6NIACT
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
MALTODEXTRIN7CVR7L4A2DIACT
ICODEXTRIN2NX48Z0A9GIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
METHYLPARABENA2I8C7HI9TIACT
ALCOHOL3K9958V90MIACT
PHOSPHORIC ACIDE4GA8884NNIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SHELLAC46N107B71OIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBIC ACIDX045WJ989BIACT
SORBITOL506T60A25RIACT
SOYBEAN LECITHIN1DI56QDM62IACT
SUCROSEC151H8M554IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
CORN OIL8470G57WFMIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tums Antacid Chewy BitesCALCIUM CARBONATE 750 MGR J General Corporation6208d11d-0670-4a20-a3fc-ebc764a8e6cd2025-11-17WarningsExact identifier
ndc (package): 70264-046-01
ndc (product): 70264-046
ndc11 (package): 70264004601
spl id: 43c91a57-26fc-ffb9-e063-6294a90a1c9e
spl set id: 6208d11d-0670-4a20-a3fc-ebc764a8e6cd
TUMSCALCIUM CARBONATEHaleon US Holdings LLC3988e3f8-b276-43a0-bdd3-01ddd422c9862024-03-03WarningsExact identifier
ndc (product): 0135-1000

Reported adverse events (FAERS/openFDA)#

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