FDA.reportPublic FDA data

Tums Chewy Bites

Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2024-04-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:05:49

Label at a glance#

ProductTums Chewy Bites
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 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 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

Questions?

OTC - QUESTIONS SECTION

Call 1-800-897-7535

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Handy Solutions® Guarantee If dissatisfied with this product, return it with a brief explanation to 5330 Fox Street, Denver, CO 80216. We'll replace it free of charge and refund your postage. You may also call 1-800-525-5097 for customer service, 9am to 4pm MST, weekdays or email us at customerservice@navajoinc.com.
Visit us on the web at www.navajoinc.com

Packaged and Distributed by
Navajo Mfg. Co. Inc. with permission
of GSK Consumer Healthcare
©2019 GSK group of companies
or its licensor.
All rights reserved.

Tums Chewy BitesTums Chewy Bites

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-191-012024-04-15C16284748780-11030e365-3fb9-111a-e063-dadaa90a10e2TUMS CHEWY BITES
67751-191-012024-01-30C16284748780-11030e365-3fb9-111a-e063-dadaa90a10e2TUMS CHEWY BITES

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67751-19167751-191-01
0135-0618

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 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

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
23952931-9ece-c0b4-e063-6394a90ada578b8b5dec-76ac-5016-e053-2a95a90a489f2024-10-03WarningsExact identifier
spl set id: 8b8b5dec-76ac-5016-e053-2a95a90a489f
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC453ceee1-414b-4f4c-8408-eb540a79ca052024-03-02WarningsExact identifier
ndc (product): 0135-0618

Reported adverse events (FAERS/openFDA)#

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