Label: ALTRIXA OB- beta-crotene, ascorbic acid, cholecalciferol, dl-alpha tocopherol acetate, pyridoxine hci, biotin, folic acid and l-5 mthf ca salt, cyanocobalamin, calcium carbonate, megnesium oxide, ferrous fumarate, postassium iodide, thiamin hci tablet
- NHRIC Code(s): 28595-721-30
- Packager: Allegis Pharmaceuticals, Inc
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated May 30, 2025
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- Official Label (Printer Friendly)
- HEALTH CLAIM
-
STATEMENT OF IDENTITY
Serving Size: 1 Tablet
Servings Per Container: 30
Each Tablet Contains:
%DV
Vitamin A (as beta-carotene)
300 mcg RAE
66%
Vitamin C (as ascorbic acid)
125 mg
140%
Vitamin D3 (as cholecalciferol)
12.5 mcg
30%
Vitamin E (as dl-alpha-tocopheryl acetate)
4.5 mg
33%
Vitamin B6 (as pyridoxine HCl)
20 mg
1117%
Folate
(From 588 mcg folic acid
and 442 mcg L-5 MTHF ca salt)
1750 mcg DFE
437.5%
Vitamin B12 (as cyanocobalamine)
0.03 mg
650%
Biotin
30 mg
10%
Calcium (from calcium carbonate)
100 mg
7.5%
Iron (as ferrous fumarate)
15 mg
83%
Iodine (as potassium iodide)
150 mcg
100%
Magnesium (as magnesium oxide)
20 mg
5%
Thiamin (as thiamin HCI) 1.4 mg 100%
** Daily Values (DV) not established.
OTHER INGREDIENTS: Microcrystalline cellulose, powdered cellulose, silica, vegetable steric acid, croscarmellose sodium, vegetable magnesium stearate, coating (hypromellose, hydroxypropyl cellulose, titanium dioxide, polyehylene glycol).
- Description
- CONTRADINDICATIONS
- WARNING
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
-
PRECAUTION:
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 obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Prenate Max Tablets should only be used under the direction and supervision of a licensed medical practioner.
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.
- How Supplied
-
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 not an Orange Book Product.
Dispense by Prescrition**
*Allegis Pharmaceuticals, Inc. does not represent these product codes to be National Drug Codes (NDC). Product codes are formated according to standard industry practice, to meet the formatting requirements by pedigree reporting and supply-chain control including pharmacies.
** 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 administratin 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 a drug claims.
1. Federal Register Notice of August 2, 1973 (38 FR 20750)
2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
3. Federal Register Notice of March 5, 1996 (61 FR 8760)
- STORAGE
- Label
-
INGREDIENTS AND APPEARANCE
ALTRIXA OB
beta-crotene, ascorbic acid, cholecalciferol, dl-alpha tocopherol acetate, pyridoxine hci, biotin, folic acid and l-5 mthf ca salt, cyanocobalamin, calcium carbonate, megnesium oxide, ferrous fumarate, postassium iodide, thiamin hci tabletProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:28595-721 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 125 mg BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE 300 ug CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 12.5 ug .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 4.5 mg PYRIDOXINE HCL (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 20 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1750 ug CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 0.03 mg BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 30 ug CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 100 mg FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 15 mg POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 150 ug MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION 20 mg THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.4 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CELLULOSE ACETATE (UNII: 3J2P07GVB6) SILICA (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:28595-721-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 05/30/2025 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape imprint size (solid drugs) 19 mm scoring 1 Labeler - Allegis Pharmaceuticals, Inc (792272861)