FDA.reportPublic FDA data

Tums Chewy Bites

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:09:19

Label at a glance#

ProductTums Chewy Bites
Active ingredientCALCIUM CARBONATE
Label structure15 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 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
  • 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)

Inactive ingredients (Mixed Berry)

INACTIVE INGREDIENT SECTION

Acacia gum, alcohol, ammonium hydroxide, beeswax, carmine, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, ethyl acetate, ethyl alcohol, FD&C blue #1 alum lake, FD&C blue #2 alum lake, FD&C red #40 alum lake, FD&C yellow #6 alum lake, flavors, gum arabic, isopropyl alcohol, maltodextrin, methylparaben, n-butyl alcohol, phosphoric acid, propylparaben, propylene glycol, purified water, shellac, sorbic acid, sorbitol, soybean oil, soy lecithin, sucrose, TBHQ, titanium dioxide, vegetable oil

Inactive Ingredients (Berries & Cream)

INACTIVE INGREDIENT SECTION

alcohol, ammonium hydroxide, beeswax, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no.1 aluminum lake, FD&C red no. 40, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum lake, flavors, gum arabic, isopropyl alcohol, lecithin, maltodextrin, medium chain triglycerides, methylparaben, modified starch, n-butyl alcohol, phosphoric acid, propylene glycol, propylparaben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soybean oil, sucrose, tert-butylhydroquinone, titanium dioxide, vegetable oil

Inactive Ingredients (Lemonade)

INACTIVE INGREDIENT SECTION

alcohol, ammonium hydroxide, beeswax, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, DL-alpha tocopherol, ethyl acetate, FD&C blue no.1 aluminum lake, FD&C blue no.2 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum lake, flavors, gum arabic, isopropyl alcohol, lecithin, maltodextrin, medium chain triglycerides, methylparaben, modified starch, n-butyl alcohol, phosphoric acid, propylene glycol, propylparaben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soybean oil, sucrose, tert-butylhydroquinone, titanium dioxide, vegetable oil

Inactive Ingredients (Lemon & Blueberry)

INACTIVE INGREDIENT SECTION

alcohol, ammonium hydroxide, beeswax, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no.1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum lake, flavors, gum arabic, isopropyl alcohol, lecithin, maltodextrin, medium chain triglycerides, methylparaben, modified starch, n-butyl alcohol, phosphoric acid, propylene glycol, propylparaben, purified water, shellac, sorbic acid, sorbitol, soybean oil, sucrose, tert-butylhydroquinone, titanium dioxide, vegetable oil

Questions?

OTC - QUESTIONS SECTION

Call 1-800-897-7535

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0618-01

TUMS ®

CALCIUM CARBONATE

ANTACID

Chewy Bites

Mixed Berry

NEW

GOES TO WORK IN SECONDS!

EXTRA STRENGTH 750

2 CHEWABLE TABLETS

Safety sealed : Do not use if packet is damaged or open.

Distributed by:

GSKConsumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2016 GSK or its licensor

105902XA

C:\Users\sh821028\Pictures\105902XA_TUMS_CB_Mixed Berry_Tabs_2ct_Pch.jpg
C:\Users\sh821028\Pictures\105902XA_TUMS_CB_Mixed Berry_Tabs_2ct_Pch.jpg

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0631-01

TUMS

CALCIUM CARBONATE

ANTACID

Chewy Bites

Berries & Cream

Made in the USA

GOES TO WORK IN SECONDS!

EXTRA STRENGTH 750

32 CHEWABLE TABLETS

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

Distributed by: GSKConsumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2018 GSK or its licensor.

1000037

1000037_TUMS Chewy Bites Berries and Cream_32 Chewable Tablets.JPG
1000037_TUMS Chewy Bites Berries and Cream_32 Chewable Tablets.JPG

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0630-01

TUMS

CALCIUM CARBONATE

ANTACID

Chewy Bites

lemonade

Limited Edition

GOES TO WORK IN SECONDS!

EXTRA STRENGTH 750

60 CHEWABLE TABLETS

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

Distributed by: GSKConsumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2018 GSK or its licensor.

1000034

1000034_TUMS Chewy Bites Lemonade_60 ct.JPG
1000034_TUMS Chewy Bites Lemonade_60 ct.JPG

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0633-01

TUMS

CALCIUM CARBONATE

ANTACID

Chewy Bites

Lemon & Blueberry

Limited Edition

GOES TO WORK IN SECONDS!

EXTRA STRENGTH 750

32 CHEWABLE TABLETS

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

Distributed by: GSKConsumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2019 GSK or its licensor.

1000290

1000290_TUMS Chewy Bites Lemon & Blueberry_32 ct.JPG
1000290_TUMS Chewy Bites Lemon & Blueberry_32 ct.JPG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN6
1044532Tums Extra Strength 750 MG (Ca 300 MG) Chewable TabletPSN6
1044532calcium carbonate 750 MG Chewable Tablet [Tums]SBD6
308915calcium carbonate 750 MG Chewable TabletSCD6
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY6
1044532Tums Chewy Bites 750 MG Chewable TabletSY6
1044532Tums E-X 750 MG (calcium 300 MG) Chewable TabletSY6
1044532Tums Kids 750 MG Chewable TabletSY6
1044532Tums Smoothies 750 MG Chewable TabletSY6

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0618-01Tums Chewy Bites2 in 1 POUCHTABLET, CHEWABLE26
0135-0630-01Tums Chewy Bites60 in 1 CONTAINERTABLET, CHEWABLE606
0135-0631-01Tums Chewy Bites32 in 1 CONTAINERTABLET, CHEWABLE326
0135-0633-01Tums Chewy Bites32 in 1 BOTTLETABLET, CHEWABLE326

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0618TUMS CHEWY BITES (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 1 package rows20240304_453ceee1-414b-4f4c-8408-eb540a79ca05.zip
0135-0630TUMS CHEWY BITES (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 1 package rows20240304_453ceee1-414b-4f4c-8408-eb540a79ca05.zip
0135-0631TUMS CHEWY BITES (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 1 package rows20240304_453ceee1-414b-4f4c-8408-eb540a79ca05.zip
0135-0633TUMS CHEWY BITES (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 1 package rows20240304_453ceee1-414b-4f4c-8408-eb540a79ca05.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-06180135-0618-01
0135-06310135-0631-01
0135-06300135-0630-01
0135-06330135-0633-01

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 141 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACACIA5C5403N26OIACT
ALCOHOL3K9958V90MIACT
AMMONIA5138Q19F1XIACT
YELLOW WAX2ZA36H0S2VIACT
CARMINIC ACIDCID8Z8N95NIACT
CARNAUBA WAXR12CBM0EIZIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCONUT OILQ9L0O73W7LIACT
STARCH, CORNO8232NY3SJIACT
CORN SYRUP9G5L16BK6NIACT
ICODEXTRIN2NX48Z0A9GIACT
ETHYL ACETATE76845O8NMZIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALUMINUM OXIDELMI26O6933IACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ISOPROPYL ALCOHOLND2M416302IACT
MALTODEXTRIN7CVR7L4A2DIACT
METHYLPARABENA2I8C7HI9TIACT
BUTYL ALCOHOL8PJ61P6TS3IACT
PHOSPHORIC ACIDE4GA8884NNIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SHELLAC46N107B71OIACT
SORBIC ACIDX045WJ989BIACT
SORBITOL506T60A25RIACT
SOYBEAN OIL241ATL177AIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SUCROSEC151H8M554IACT
TERT-BUTYLHYDROQUINONEC12674942BIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CORN OIL8470G57WFMIACT
CALCIUM CARBONATEH0G9379FGKACTIB
ALCOHOL3K9958V90MIACT
AMMONIA5138Q19F1XIACT
YELLOW WAX2ZA36H0S2VIACT
CARNAUBA WAXR12CBM0EIZIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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 LLC453ceee1-414b-4f4c-8408-eb540a79ca052024-03-02WarningsExact identifier
ndc (package): 0135-0633-01
ndc (package): 0135-0630-01
ndc (package): 0135-0631-01
ndc (package): 0135-0618-01
ndc (product): 0135-0633
ndc (product): 0135-0631
ndc (product): 0135-0630
ndc (product): 0135-0618
ndc11 (package): 00135063301
ndc11 (package): 00135061801
ndc11 (package): 00135063101
ndc11 (package): 00135063001
spl id: 12b764a2-fe05-5019-e063-6394a90a7c6f
spl set id: 453ceee1-414b-4f4c-8408-eb540a79ca05

Reported adverse events (FAERS/openFDA)#

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