FDA.reportPublic FDA data

Titralac Plus

Manufacturer
iNova Pharmaceuticals Pty, Ltd
Effective date
2011-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:51

Label at a glance#

ProductTitralac Plus
Active ingredientCalcium Carbonate, dimethicone
Label structure8 sections

Indications and uses

relieves symptoms referred to as gas relieves: heartburn sour stomach acid indigestion

Dosage and administration

chew, swallow or let melt in mouth two tablets every two or three hours as symptoms occur or as directed by a physician do not take more than 19 tablets in a 24 hour period or use maximum dosage for more than two weeks

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Calcium carbonate 420 mg

(168 mg elemental calcium)

Simethicone 21 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Antigas

Uses

INDICATIONS & USAGE SECTION

  • relieves symptoms referred to as gas
  • relieves:
    • heartburn
    • sour stomach
    • acid indigestion

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms last for more than 2 weeks.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew, swallow or let melt in mouth two tablets every two or three hours as symptoms occur or as directed by a physician
  • do not take more than 19 tablets in a 24 hour period or use maximum dosage for more than two weeks

Other information

SPL UNCLASSIFIED SECTION

  • sugar free
  • very low sodium content (1.5 mg/tablet)
  • low aluminum content (1.0 mg/tablet)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycine, magnesium stearate, saccharin, spearmint oil, starch

  • may also contain croscarmellose sodium

For your protection this bottle has a printed foil seal under the cap.

For Information: 1-800-537-2191

Made in Australia for 3M

3M Consumer Health Care

St. Paul, MN 55144-1000

© 3M 2008 Cat. 360-10

3M and Titralac are trademarks of 3M.

T7562

Principal Display Panel – Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPEARMINT FLAVOR

NDC 055298-013-10

FAST RELIEF

Titralac™

PLUS ANTACID

Simethicone Anti-Gas Formula

Calcium Rich • Sugar Free

Low Aluminum • Very Low Sodium

100 TABLETS 3M

Principal Display Panel – Bottle Label
Principal Display Panel – Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
237867calcium carbonate 420 MG (Ca 168) / simethicone 21 MG Chewable TabletPSN1
701678calcium carbonate 420 MG / simethicone 21 MG Chewable Tablet [Titralac Plus]SBD1
237867calcium carbonate 420 MG / simethicone 21 MG Chewable TabletSCD1
701678Titralac Plus (calcium carbonate 420 MG / simethicone 21 MG) Chewable TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55298-013-102019-10-29C16284748780-1960f7f55-c56f-8e05-e053-dbdaa90a074a68725b83-46fc-47ae-bb5c-51f080dcacfe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55298-013-10Titralac Plus100 in 1 BOTTLE, PLASTICTABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55298-013TITRALAC PLUS (CALCIUM CARBONATE, DIMETHICONE) TABLET [INOVA PHARMACEUTICALS PTY, LTD]1Legacy NDC, 1 package rows20110428_68725b83-46fc-47ae-bb5c-51f080dcacfe.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Calcium CarbonateACTIVE INGREDIENTH0G9379FGK1
dimethiconeACTIVE INGREDIENT92RU3N3Y1O1
CalciumACTIVE MOIETYSY7Q814VUP1
dimethiconeACTIVE MOIETY92RU3N3Y1O1
glycineINACTIVE INGREDIENTTE7660XO1C1
magnesium stearateINACTIVE INGREDIENT70097M6I301
saccharinINACTIVE INGREDIENTFST467XS7D1
spearmint oilINACTIVE INGREDIENTC3M81465G51
starch, cornINACTIVE INGREDIENTO8232NY3SJ1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55298-01355298-013-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Calcium CarbonateH0G9379FGKACTIB
dimethicone92RU3N3Y1OACTIB
glycineTE7660XO1CIACT
magnesium stearate70097M6I30IACT
saccharinFST467XS7DIACT
spearmint oilC3M81465G5IACT
starch, cornO8232NY3SJIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 104 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, DELAYED RELEASE / ORAL144 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30SUSPENSION, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
39 equally ranked IID candidates
glycineGLYCINETE7660XO1CPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
20 equally ranked IID candidates
saccharinSACCHARINFST467XS7DPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
16 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
saccharinSACCHARINFST467XS7DSOLUTION / ORAL150 mgExact identifier — unii candidate
16 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
glycineGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR40 mgExact identifier — unii candidate
20 equally ranked IID candidates
saccharinSACCHARINFST467XS7DTABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
16 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
22 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
39 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET, DELAYED RELEASE / ORAL713 mgExact identifier — unii candidate
22 equally ranked IID candidates
glycineGLYCINETE7660XO1CPOWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii candidate
20 equally ranked IID candidates
saccharinSACCHARINFST467XS7DAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJSUSPENSION, EXTENDED RELEASE / ORAL113 mgExact identifier — unii candidate
22 equally ranked IID candidates
glycineGLYCINETE7660XO1CINJECTION / INTRAMUSCULAR68 mgExact identifier — unii candidate
20 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJSUSPENSION / ORAL900 mgExact identifier — unii candidate
22 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30RING / VAGINAL2 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
spearmint oilSPEARMINT OILC3M81465G5SUSPENSION / ORAL0.59 mg/20mlExact identifier — unii candidate
7 equally ranked IID candidates
saccharinSACCHARINFST467XS7DELIXIR / ORAL2 mg/1mlExact identifier — unii candidate
16 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
glycineGLYCINETE7660XO1CTABLET / ORAL163.31 mgExact identifier — unii candidate
20 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii candidate
22 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii candidate
39 equally ranked IID candidates
glycineGLYCINETE7660XO1CCAPSULE, DELAYED RELEASE / ORAL50 mgExact identifier — unii candidate
20 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING / ORAL100 mgExact identifier — unii candidate
22 equally ranked IID candidates
saccharinSACCHARINFST467XS7DPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
16 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii candidate
39 equally ranked IID candidates
glycineGLYCINETE7660XO1CINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS10 mgExact identifier — unii candidate
20 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL21 mgExact identifier — unii candidate
22 equally ranked IID candidates
saccharinSACCHARINFST467XS7DTABLET, CHEWABLE / ORAL0.9 mgExact identifier — unii candidate
16 equally ranked IID candidates
saccharinSACCHARINFST467XS7DTABLET / ORAL1.6 mgExact identifier — unii candidate
16 equally ranked IID candidates
spearmint oilSPEARMINT OILC3M81465G5TABLET / SUBLINGUAL0.4 mgExact identifier — unii candidate
7 equally ranked IID candidates
saccharinSACCHARINFST467XS7DOINTMENT / TOPICAL0.5 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJPOWDER, FOR SUSPENSION / ORAL34 mgExact identifier — unii candidate
22 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
glycineGLYCINETE7660XO1CINJECTION / INTRAVENOUS200 mgExact identifier — unii candidate
20 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
39 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET / SUBLINGUAL409 mgExact identifier — unii candidate
22 equally ranked IID candidates
spearmint oilSPEARMINT OILC3M81465G5OINTMENT / TOPICALNAExact identifier — unii candidate
7 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii candidate
22 equally ranked IID candidates
glycineGLYCINETE7660XO1CCAPSULE / ORAL62 mgExact identifier — unii candidate
20 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii candidate
22 equally ranked IID candidates
saccharinSACCHARINFST467XS7DPASTE, DENTIFRICE / DENTAL0.23 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
glycineGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / INTRADERMAL0.5 mgExact identifier — unii candidate
20 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, FOR SUSPENSION / ORAL131 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
39 equally ranked IID candidates
spearmint oilSPEARMINT OILC3M81465G5CAPSULE / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
glycineGLYCINETE7660XO1CINJECTABLE, LIPOSOMAL / INTRAVENOUS0.38 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
glycineGLYCINETE7660XO1CINJECTION, SOLUTION / INTRAVENOUS0.42 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJPASTILLE / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates

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
8e9a93d6-f0ff-4ea5-bed9-688ab924aa8568725b83-46fc-47ae-bb5c-51f080dcacfe2011-05-01WarningsExact identifier
spl id: 8e9a93d6-f0ff-4ea5-bed9-688ab924aa85
spl set id: 68725b83-46fc-47ae-bb5c-51f080dcacfe

Reported adverse events (FAERS/openFDA)#

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