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Maxfe Tablets

Generic name: ascorbic acid, folic acid, cyanocobalamin, biotin, iron, magnesium, zinc and docusate sodium
Dosage form: tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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.

MAXFE
ascorbic acid, folic acid, vitamin b-12, biotin, iron, magnesium, zinc tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67555-140
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 60 ug
BIOTIN (BIOTIN) BIOTIN 150 ug
IRON (IRON) IRON 160 mg
MAGNESIUM (MAGNESIUM) MAGNESIUM 6.5 mg
ZINC (ZINC) ZINC 12 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
STEARIC ACID
CITRIC ACID MONOHYDRATE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CROSPOVIDONE
SODIUM BENZOATE
SODIUM LAURYL SULFATE
SILICON DIOXIDE
SOY PROTEIN
POVIDONE
TALC
HYPROMELLOSES
POLYETHYLENE GLYCOLS
FD&C YELLOW NO. 6
Product Characteristics
Color orange (Orange/Gray) Score no score
Shape capsule Size 20mm
Flavor Imprint Code MAXFE
Contains
Packaging
# Item Code Package Description
1 NDC:67555-140-12 120 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2014
Labeler - Pronova Corporation (111421496)
Pronova Corporation