Label: MAXFE- magnesium ascorbate, l-5 methyltetrahydrofolate calcium, cyanocobalamin, biotin, carbonyl iron, ferrous bisglycinate chelate, zinc bis-glycinate chelate tablet
- NHRIC Code(s): 67555-141-12
- Packager: Pronova Corporation
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated May 16, 2023
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STATEMENT OF IDENTITY
Supplement Facts
Serving Size: 1 Tablet / Servings Per Container: 120Amount Per Serving
% Daily Value
Vitamin C (as Magnesium Ascorbate) 100 mg 111% Folate (as L-5 Methyltetrahydrofolate
Calcium)1.7 mg DFE 425% Vitamin B12 (as Cyanocobalamin) 60 mcg 2500% Biotin 150 mcg 500% Iron (as Carbonyl Iron and Ferrous Bisglycinate
Chelate (Ferrochel®))160 mg 889% Zinc (as Zinc bis-glycinate chelate -TRAACS®)# 12 mg 109% * Daily Value not established OTHER INGREDIENTS: Microcrystalline Cellulose, Dicalcium Phosphate, Citric Acid, Stearic Acid, Croscarmellose Sodium, Silicon Dioxide, Magnesium Stearate, Pharmaceutical Glaze, Crospovidone, Sodium Benzoate, Sodium Lauryl Sulfate, Soy Polysaccharide, Polyvinylpyrrolidone, Maltodextrin, Sucrose, Hypromellose, Polyethylene Glycol, FD&C Yellow #6 Lake, Artificial French Vanilla Flavor, Propylene Glycol, Starch, Tricalcium Phosphate and Talc.
Contains: Soy
DESCRIPTION: MaxFeTM is a multivitamin / multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.†
†This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease. -
WARNINGS
WARNING: Accidental overdose of iron-containing products is leading a cause of fatal poisoning in children under 6 years of age. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately. DO NOT USE MAXFeTM for individuals with a known hypersensitivity to any of the ingredients. Patients with hemochromatosis and hemosiderosis. The product is not for use in children under 12 years of age.
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CAUTION:
This product contains 1 mg folic acid, the maximum safe Reference Daily Intake (RDI) amount for this nutrient. Folic Acid alone should not be used for individuals with pernicious anemia and other megaloblastic anemias where Vitamin B-12 is deficient. Folic acid in amounts above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Pregnant women, nursing mothers or women prior to conception who take MAXFeTM should take this supplement only after their medical condition and other drugs, herbs and/or supplements consumption are considered. Use for elderly individuals should be cautious due to the greater frequency of decreased hepatic, renal, or cardiac function.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
- DIRECTIONS FOR USE:
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OTHER INFORMATION:
MAXFeTM is supplied in child-resistant trade bottles of 120 and 30 caplets and physician samples in child-resistant bottles of 4 caplets. Store at controlled room temperature 59°-86°F. See USP Controlled Room Temperature.
To report a serious advent event or to obtain product information, contact (866) 703-3508.
Distributed by:
Pronova Corporation
Miami, Florida 33155 - HEALTH CLAIM
- Packaging
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INGREDIENTS AND APPEARANCE
MAXFE
magnesium ascorbate, l-5 methyltetrahydrofolate calcium, cyanocobalamin, biotin, carbonyl iron, ferrous bisglycinate chelate, zinc bis-glycinate chelate tabletProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:67555-141 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM ASCORBATE (UNII: 0N1G678593) (ASCORBIC ACID - UNII:PQ6CK8PD0R) MAGNESIUM ASCORBATE 100 mg LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM 1 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 60 ug BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 150 ug FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 160 mg ZINC GLYCINATE (UNII: 681VJX72FE) (ZINC CATION - UNII:13S1S8SF37) ZINC GLYCINATE 12 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) STEARIC ACID (UNII: 4ELV7Z65AP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) SHELLAC (UNII: 46N107B71O) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SOYBEAN COTYLEDON CELL WALL POLYSACCHARIDES (UNII: 4UL6DF56YQ) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCROSE (UNII: C151H8M554) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STARCH, RICE (UNII: 4DGK8B7I3S) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:67555-141-12 120 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 03/29/2023 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 21 mm scoring 3 imprint flavor Labeler - Pronova Corporation (111421496)
