FDA.reportPublic FDA data

TUMS

Manufacturer
RedPharm Drug
Effective date
2024-07-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:17

Label at a glance#

ProductTUMS Smoothies
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 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 10 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 tablet contains:elemental calcium 300mg
  • store below 25 oC (77 oF). Keep the container tightly closed.

Inactive ingredients (Assorted Fruit)

INACTIVE INGREDIENT SECTION

adipic acid, corn starch, dextrose, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Contains: soy

Inactive ingredients (Berry Fusion)

INACTIVE INGREDIENT SECTION

adipic acid, corn starch, dextrose, FD&C blue #1 lake, FD&C red #40 lake, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Contains: soy

Inactive ingredient (Assorted Tropical Fruit)

INACTIVE INGREDIENT SECTION

adipic acid, corn starch, dextrose, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Contains: soy

Inactive ingredients (Peppermint)

INACTIVE INGREDIENT SECTION

corn starch, dextrose, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Questions?

OTC - QUESTIONS SECTION

1-800-897-7535weekdays

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0246-02

TUMS ®

CALCIUM CARBONATE

ANTACID

SmoothiesTM

Assorted Fruit

SMOOTH DISSOLVE

EXTRA STRENGTH 750

GOES TO WORK IN SECONDS!

60CHEWABLE TABLETS

PAREVE

©2014 GSK

Safety sealed – Do not use if printed inner seal beneath cap is missing or broken.

GlaxoSmithKline

Moon Twp, PA 15108

Gluten-Free

www.tums.com

Front Panel 103644XA

Back Panel 103553XA

Tums Smoothies Assorted Fruit 60 count front label
Tums Smoothies Assorted Fruit 60 count front label

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0456-03

TUMS ®

CALCIUM CARBONATE

ANTACID

SmoothiesTM

Berry Fusion

SMOOTH DISSOLVE

EXTRA STRENGTH 750

GOES TO WORK IN SECONDS!

60CHEWABLE TABLETS

PAREVE

Safety sealed – Do not use if printed inner seal beneath cap is missing or broken.

GSKCH

Warren, NJ 07059

Gluten-Free

©2014 GSK

Front Panel 103680XA

Back Panel 103725XA

Tums Smoothies Berry Fusion 60 count front label
Tums Smoothies Berry Fusion 60 count front label

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0245-02

TUMS ®

CALCIUM CARBONATE

ANTACID

SmoothiesTM

Tropical Fruit

SMOOTH DISSOLVE

EXTRA STRENGTH 750

GOES TO WORK IN SECONDS!

60CHEWABLE TABLETS

PAREVE

©2014 GSK

Safety sealed – Do not use if printed inner seal beneath cap is missing or broken.

GlaxoSmithKline

Moon Twp, PA 15108

Gluten-Free

www.tums.com

Front Panel 103818XA

Back Panel 103816XA

Tums Smoothies Tropical Fruit 60 count front label
Tums Smoothies Tropical Fruit 60 count front label

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0243-02

TUMS ®

CALCIUM CARBONATE

ANTACID

SmoothiesTM

Peppermint

SMOOTH DISSOLVE

EXTRA STRENGTH 750

GOES TO WORK IN SECONDS!

60CHEWABLE TABLETS

PAREVE

Safety sealed – Do not use if printed inner seal beneath cap is missing or broken.

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

GSKConsumer Healthcare

Warren, NJ 07059

Gluten-Free

©2015 GSK or its licensor.

Front Panel 103728XB

Back Panel 103727XB

Tums Smoothies Peppermint 60 count front label
Tums Smoothies Peppermint 60 count front label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN1
1044532Tums Extra Strength 750 MG (Ca 300 MG) Chewable TabletPSN1
1044532calcium carbonate 750 MG Chewable Tablet [Tums]SBD1
308915calcium carbonate 750 MG Chewable TabletSCD1
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY1
1044532Tums Chewy Bites 750 MG Chewable TabletSY1
1044532Tums E-X 750 MG (calcium 300 MG) Chewable TabletSY1
1044532Tums Kids 750 MG Chewable TabletSY1
1044532Tums Smoothies 750 MG Chewable TabletSY1

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
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
67296-1256-1TUMSSmoothies12 in 1 BOTTLETABLET, CHEWABLE121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1256TUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [REDPHARM DRUG]11 package rows20240716_1d544441-ff1d-64f4-e063-6294a90a8fc8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0246-01EA - Each0135-02465df3290b-bb27-4cf8-8c86-9f263280492912016-09-02
0135-0246-02EA - Each0135-0246c7ecf7e3-0cbe-4c74-82a8-1255abe39cc412012-07-24
0135-0246-05EA - Each0135-02460d587724-8816-4b35-b318-9c01d518367512025-05-14
0135-0246-07EA - Each0135-0246f1522a31-bec4-48e3-9df0-ead5213d27e312017-03-06

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67296-125667296-1256-1
0135-0246

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADIPIC ACID76A0JE0FKJIACT
STARCH, CORNO8232NY3SJIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALUMINUM OXIDELMI26O6933IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GUAR GUME89I1637KEIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SORBITOL506T60A25RIACT
SUCROSEC151H8M554IACT
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 SmoothiesCALCIUM CARBONATEHaleon US Holdings LLCc22944b8-8733-4689-be0c-f320467f79ea2026-04-01WarningsExact identifier
ndc (product): 0135-0246
1d543581-3e1f-4deb-e063-6294a90a74871d544441-ff1d-64f4-e063-6294a90a8fc82024-07-15WarningsExact identifier
spl id: 1d543581-3e1f-4deb-e063-6294a90a7487
spl set id: 1d544441-ff1d-64f4-e063-6294a90a8fc8

Reported adverse events (FAERS/openFDA)#

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