MAXFE- magnesium ascorbate, l-5 methyltetrahydrofolate calcium, cyanocobalamin, biotin, carbonyl iron, ferrous bisglycinate chelate, zinc bis-glycinate chelate tablet

MaxFe by

Drug Labeling and Warnings

MaxFe by is a Other medication manufactured, distributed, or labeled by Pronova Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Supplement Facts; Serving Size: 1 Tablet / Servings Per Container: 120
	Amount 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.

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:

One caplet daily with or without food or as recommended by your healthcare provider.

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

Fe With FERROCHEL®

Vitamin & Mineral Supplement with Iron

Bilayered Hematinic Caplets

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

EP2008/052034
#Ferrochel® TRAACS® are registered
trademark of Albion Laboratories, Inc.,
covered by U.S.
Patents 6,716,814
and 7,838,042.

Packaging

INGREDIENTS AND APPEARANCE

MAXFE 
magnesium ascorbate, l-5 methyltetrahydrofolate calcium, cyanocobalamin, biotin, carbonyl iron, ferrous bisglycinate chelate, zinc bis-glycinate chelate tablet

Product 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)