Label: ALTRIXA- vitamin tablet, coated
- NHRIC Code(s): 28595-715-30
- Packager: Allegis Pharmaceuticals, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated March 28, 2024
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- Suplement Facts
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Description
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
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
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.
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Warnings
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.
- Doseage and Administration
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Storage
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
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
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INGREDIENTS AND APPEARANCE
ALTRIXA
vitamin tablet, coatedProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:28595-715 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 4.5 ug .ALPHA.-TOCOPHEROL CALCIUM SUCCINATE, D- (UNII: BVK87L5TNB) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL CALCIUM SUCCINATE, D- 10 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 20 ug ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 75 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 2.5 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.6 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 16.3 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1667 ug THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.4 mg Inactive Ingredients Ingredient Name Strength CELLULOSE ACETATE (UNII: 3J2P07GVB6) STEARIC ACID (UNII: 4ELV7Z65AP) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:28595-715-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 03/28/2024 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 11 mm imprint scoring 1 Labeler - Allegis Pharmaceuticals, LLC (792272861)
