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Folet One

Generic Name: ascorbic acid, folic acid, cyanocobalamin, cholecalciferol, iron, magnesium, zinc, docusate sodium, .alpha.-tocopherol, d-, pyridoxine hydrochloride and doconexent
Dosage Form: capsule, liquid filled

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 softgel  Servings per container: 30

                       Amount per Serving     %Daily Value

Vitamin C                18 mg                       30%

Vitamin D               250 IU                        63%

Vitamin E                 15 IU                         50%

Vitamin B6               30 mg                      2500%

Folate                       1 mg                        125%

Vitamin B-12             15 mcg                    250%

Iron                          38 mg                       194%

Zinc                           20 mg                       334%

Magnesium                15 mg                           4%

Docusate Sodium         25 mg                          *

DHA                             225 mg                         *

Description

Folet One is a prescription prenatal vitamin and mineral supplementation with DHA taken throughout pregnancy and during the postnatal period for both lactating and non-lactating mother. Folet One is also useful in improving nutritional status prior to conception. It is recommended that for all women folate levels should be high for at least one month prior to possible conception and continued at that level for the first three months of pregnancy.

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 Folet One 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.

Ingestion of more than 3 grams per day of omega-3 fatty acids, such as DHA (docosahexaenoic acid) has been shown to have potential anti-thrombotic effects, including increased bleeding times. Adminitration of Folet One should be avoided in patients taking anticoagulants.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral adminitration of folic acid.

Directions for use:

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

Other Information:

Folet One is supplied in child-resistant trade bottles of 30 softgels and sample bottles of 4 softgels. Optimum storage condition= 30 to 40% relative humidity and 59 to 86 degrees F (15-30 degrees C). Protect from extreme temperature. Freezing and excessive heat may damage softgels.

Folet One 
vitamin c, vitamin d, vitamine e, vitamine b6, folate, vitamine b12, iron, zinc, magnesium, docusate sodium, dha capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67555-154
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 18 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 15 ug
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 250 [iU]
IRON (IRON) IRON 38 mg
MAGNESIUM (MAGNESIUM) MAGNESIUM 15 mg
ZINC (ZINC) ZINC 20 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 25 mg
.ALPHA.-TOCOPHEROL, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 15 [iU]
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 30 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 225 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
SOY PROTEIN  
WATER  
WHITE WAX  
TITANIUM DIOXIDE  
FD&C RED NO. 40  
FD&C BLUE NO. 1  
Product Characteristics
Color purple Score no score
Shape OVAL Size 18mm
Flavor Imprint Code none
Contains         
Packaging
# Item Code Package Description
1 NDC:67555-154-30 30 CAPSULE, LIQUID FILLED 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)
Revised: 07/2014
 
Pronova Corporation
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