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Maxfe Tablets Prescribing Information

Package insert / product label
Generic name: ascorbic acid, folic acid, cyanocobalamin, biotin, iron, magnesium, zinc and docusate sodium
Dosage form: tablet

Serving Size: 1 caplet Servings per container: 120

Amount per Serving %Daily Value

Vitamin C 100 mg 167%

Folate 1 mg 250%

Vitamin B-12 60 mcg 1000%

Biotin 150 mcg 50%
Iron 160 mg 889%

Magnesium 6.5 mg 2%

Zinc 12 mg 80%

Docusate Sodium 50 mg *

Description

MaxFe is a prescription multivitamin/multimineral dietary supplement for adults 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.

Warning:

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDRE. In case of accidental overdose, call a doctor or poison control center immediately.

Do Not Use

Do not use MaxFe 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 MaxFe 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 adminitration of folic acid.

Directions for use:

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

Other Information:

MaxFe 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 degrees F. See USP Controlled Room Temperature.

MaxFeLabel

MAXFE
ascorbic acid, folic acid, vitamin b-12, biotin, iron, magnesium, zinc tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67555-140
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN60 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN150 ug
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON160 mg
MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM6.5 mg
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC12 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
STEARIC ACID (UNII: 4ELV7Z65AP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSPOVIDONE (UNII: 68401960MK)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SOY PROTEIN (UNII: R44IWB3RN5)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
Product Characteristics
Colororange (Orange/Gray) Scoreno score
ShapecapsuleSize20mm
FlavorImprint CodeMAXFE
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67555-140-12120 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2014
Labeler - Pronova Corporation (111421496)