FDA.reportPublic FDA data

Mincora Tablets

Manufacturer
Allegis Pharmaceuticals, LLC
Effective date
2025-01-06
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:51:23

Label at a glance#

ProductMincora
Active ingredientCYANOCOBALAMIN, CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, N-ACETYL-L-CYSTEINE 2-DEOXY-3-THIO-D-ERYTHRO-PENTONIC ACID .GAMMA.-LACTONE THIOETHER
Label structure7 sections

Label contents#

Full prescribing information#

Suplement Facts

STATEMENT OF IDENTITY SECTION

image descriptionimage description

Other Ingredients:

INACTIVE INGREDIENT SECTION

Microcrystalline cellulose, powder cellulose,vegetable stearic acid, silica, croscarmellose sodium, vegetable megnesium stearate, hydroxypropyl methylcellulose (HPMC), titanium oxide. 

Precautions

PRECAUTIONS SECTION

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamine B12 is deficient.  

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.  Mincora Tablets should only be used under the direction and supervision of a licensed medical practitioner. 

Contraindications

CONTRAINDICATIONS SECTION

Mincora Tablets are contraindicated in patients with a know hypersensitivity to any of the contained ingredients.  Do not take this product if you are presently taking mineral oil, unless directed by a licensed medical practitioner. 

Warnings

WARNINGS SECTION

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

In case of accidental overdose, call a licensed medical practitioner or poison control center immediately.  

For use under the supervision of a licensed medical practitioner.  

Dispense in a tight, light resistant container as defined in the USP/NF in a child-resistant closure.  

Adverse Reactions

ADVERSE REACTIONS SECTION

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You may report side effects by calling Allegis Pharmaceuticals at 1-866-633-9033 or the FDA by calling 1-800-FDA-1088

Dosage and Adminstration

DOSAGE & ADMINISTRATION SECTION

Description: Mincora Tablets is a prescription dietary supplement intended for oral adminstration.

Indication and Usage: Mincora Tablets is to privide significant amounts of Vitamins B6, B12, D3, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitaines will not develop. 

Dosage: Usual adult dose is one tablet daily, or as prescribed by a licensed medical practitioner.

Storage

SAFE HANDLING WARNING SECTION

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light and moisture.Tamper Evident: Do not use if seal if broken or missing.

Statements

SPL UNCLASSIFIED SECTION

† This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760). 1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription. This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable.

The ingredients, indication or claims of this product are not to be construed to be drug claims.

1. Federal Register Notice of August 2, 1973 (38 FR20750) 2. Federal Register Notice of October 17, 1980 (45 FR69043, 69044)  3. Federal Register Notice of March 5, 1996 (61 FR 8760)

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

How Supplied

HEALTH CLAIM SECTION

Mincora Tablets: Each bottle contains 30 tablets (white) (28595-716-30)

Mincora Tablets are avaiable as white, round tablets with F100 imprint and are available in 30 count bottles (28595-716-30)

These Statements have note been evaluated by the FDA.  This product is not intended to diagnose, treat, cure, or prevent any disease. 

Manufactured in the USA for:

Allegis Pharmaceuticals, LLC

Canton, MS  39046

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
28595-716-30Mincora30 in 1 BOTTLETABLET, COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28595-716MINCORA (VITAMIN) TABLET, COATED [ALLEGIS PHARMACEUTICALS, LLC]11 package rows20250109_43370639-bed3-4b20-9682-3045fa85b213.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-716-30EA - Each28595-716585b1a97-2e30-4ffe-b4cf-d6b42655e4ec12025-02-10

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
28595-71628595-716-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYANOCOBALAMINP6YC3EG204ACTIB
CHOLECALCIFEROL1C6V77QF41ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
FOLIC ACID935E97BOY8ACTIB
CELLULOSE ACETATE3J2P07GVB6IACT
STEARIC ACID4ELV7Z65APIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
N-ACETYL-L-CYSTEINE 2-DEOXY-3-THIO-D-ERYTHRO-PENTONIC ACID .GAMMA.-LACTONE THIOETHERKX2B81V402ACTIB
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
HYDROXYPROPYL METHYLCELLULOSE3NXW29V3WOIACT

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirst54f088b1-7cf8-3837-e063-6294a90a88e72026-09-02Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINLifestar Pharma LLCb1e35c97-2157-454e-967f-53a4300827de2026-08-06Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINNorthStar RxLLCce0183b3-4410-466a-b57d-cd360d461b7c2026-08-06Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
Non-proprietary nameCYANOCOBALAMINXseer Pharmaceuticals3bb870d8-128d-75ea-e063-6394a90a707b2026-05-13Name fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINPlano Pharmaceuticals Inc.4cbc05f6-4b31-4a5f-e063-6394a90a676c2026-03-25Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
cyanocobalaminCYANOCOBALAMINSportpharm LLC647842f4-b211-4f52-8b73-975fae7670232026-02-05Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINA-S Medication Solutionsa61181f5-7e2d-45f9-929a-cb8bc70c992e2026-01-06Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINSOLA Pharmaceuticalse559c6c8-2973-77fb-e053-2995a90af43d2025-12-08Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINBluePoint Laboratories5c603ad0-9023-44cc-955c-3988d5dcf0d32025-12-05Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CYANOCOBALAMINCYANOCOBALAMINHenry Schein, Inc.ff32f34b-89b3-4617-ad42-2e8bcb88627e2025-10-16Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINHenry Schein, Inc.92f08572-cfd9-4a99-bb49-937ab94eeb622025-09-10Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
cyanocobalaminCYANOCOBALAMINSomerset Therapeutics, LLC41ac0dc1-0a71-4c69-8e25-ba838f5f16a32025-09-04Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CYANOCOBALAMINCYANOCOBALAMINSomerset Therapeutics, LLC617e44f8-df80-4764-85b9-be0fb6da8db32025-08-29Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINMeitheal Pharmaceuticals Inc.064c6841-3ed2-417f-a77c-a730785b60362025-06-12Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirst9d4ac337-5f4d-ef47-e053-2a95a90a6dbf2025-01-08Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINVitruvias Therapeutics2117af8a-723f-4e2f-98a6-83ad2c4237512024-12-20Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINFresenius Kabi USA, LLCacff4ff3-4435-4995-a117-dbfcdf72334a2024-12-15Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINFresenius Kabi USA, LLC8b1cdee5-3368-40e4-90bf-31a64df1f38a2024-12-12Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINMeitheal Pharmaceuticals Inc.9c37fd25-2143-410c-8d89-d39aa5c7b4532024-11-22Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINMeitheal Pharmaceuticals Inc.c6436212-9246-4e29-8540-9af992b667eb2024-06-03Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN

Reported adverse events (FAERS/openFDA)#

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