Altrix Tablets

Manufacturer
Allegis Pharmaceuticals, LLC
Effective date
2024-03-28
Label type
DIETARY SUPPLEMENT
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:06:59

Label at a glance#

ProductAltrixa
Active ingredientCYANOCOBALAMIN, .ALPHA.-TOCOPHEROL CALCIUM SUCCINATE, D-, CHOLECALCIFEROL, ASCORBIC ACID, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, FOLIC ACID, THIAMINE
Label structure6 sections

Label contents#

Full prescribing information#

Suplement Facts

STATEMENT OF IDENTITY SECTION

TableTable

Other Ingredients:

SPL UNCLASSIFIED SECTION

cellulose, vegetable stearic acid, silica, croscarmellose sodium, vegetable megnesium stearate, cellulose coating, titanium oxide. 

Description

PRECAUTIONS SECTION

Altrixa Tablets is a prescription dietary supplement intended for oral administration.  

Altrixa Tablets is to provide significant amounts of Vitamins B6, B12, C, D3, E, riboflavin, niacinamide, thiamine monoitrate, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamines will not develop.   

Contraindications

SPL UNCLASSIFIED SECTION

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

Precautions

SPL UNCLASSIFIED SECTION

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obsure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Altrxia tablets should only be used under the direction and supervision of 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

SPL UNCLASSIFIED 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

Doseage and Administration

DOSAGE & ADMINISTRATION SECTION

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

How Supplied

SPL UNCLASSIFIED SECTION

Altrix Tablets are avaialble as white, round tablets with AL07 imprint and are available in 30 count bottles (28595-715-30). 

Manufactred in the USA for:

Allegis pharmaceuticals, LLC.

Canton MS 39046

Rev. 01/2024

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

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

† 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

LabelLabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28595-715ALTRIXA (VITAMIN) TABLET, COATED [ALLEGIS PHARMACEUTICALS, LLC]1Unmatched20240331_7451c4cd-be42-475e-86f5-a0062d746f5e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-715-30EA - Each28595-7151f305694-4fd9-44e9-8426-5db53dd9e2db12024-05-16

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
28595-71528595-715-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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.