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Folet DHA

Generic Name: prenatal vitamin and mineral supplement
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.

Description

Folet DHA combination pack is a prescription prenatal vitamin and mineral supplementation with DHA taken through pregnancy and during the portnatal period for both lactating and non-lactating mothers. Folet DHA combination pack 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.

Dosage and Administration

One tablet and one softgel daily or as direct by a physician.

Contraindications

Folet DHA is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

Warnings and Precautions

WARNINGS: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

PRECAUTIONS: Folic Acid alone in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.

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 bleedng times. Administration of Folet DHA Omega-3 Fatty Acids should be avoided in patients taking anticoagulants.

Adverse Reactions

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

To report a serious adverse event or to obtain product information, contact (866) 703-3508.

Folet DHA 
dha (docosahexaenoic acid), vit.a (beta-carotine), vit.c (ascorbic acid), vit.d-3 (cholecalciferol), vit.e (d-alpha-tocopheryl acetate), vit.b-1 (thiamine hcl), vit.b-2 (riboflavin), vit.b-3 (niacinamide), vit.b-6 (pyridoxine hcl), folate (1.85 mg (6s)-5-methyltetrahydrofolate-quatrefolic), vit.b-12 (cyanocobalamin), iron (carbonyl iron -ferronyl and ferrous bis-glycinate chelate -ferrochel), magnesium (magnesium oxide), zinc (zinc bis-glycinate chelate -traacs), selenium (sodium selenate), docusate sodium kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67555-153
Packaging
# Item Code Package Description
1 NDC:67555-153-30 1 KIT in 1 PACKAGE
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 30 
Part 2 1 BOTTLE 30 
Part 1 of 2
Folet DHA 
vit.a (beta-carotine), vit.c (ascorbic acid), vit.d-3 (cholecalciferol), vit.e (d-alpha-tocopheryl acetate), vit.b-1 (thiamine hcl), vit.b-2 (riboflavin), vit.b-3 (niacinamide), vit.b-6 (pyridoxine hcl), folate (1.85 mg (6s)-5-methyltetrahydrofolate-quatrefolic), vit.b-12 (cyanocobalamin), iron (carbonyl iron -ferronyl and ferrous bis-glycinate chelate -ferrochel), magnesium (magnesium oxide), zinc (zinc bis-glycinate chelate -traacs), selenium (sodium selenate), docusate sodium tablet
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA CAROTENE (.BETA.-CAROTENE) BETA CAROTENE 2700 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 18 [iU]
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 40 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
FERROUS BISGLYCINATE (FERROUS CATION) FERROUS CATION 38 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 30 mg
ZINC GLYCINATE (ZINC CATION) ZINC GLYCINATE 10 mg
SELENIUM (SELENIUM) SELENIUM 65 ug
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
METHACRYLIC ACID  
CROSCARMELLOSE SODIUM  
GELATIN  
SHELLAC  
HYPROMELLOSES  
STEARIC ACID  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
CROSPOVIDONE  
TALC  
SODIUM BENZOATE  
SILICON DIOXIDE  
STARCH, CORN  
TRIACETIN  
TITANIUM DIOXIDE  
CITRIC ACID MONOHYDRATE  
SODIUM LAURYL SULFATE  
MAGNESIUM STEARATE  
SOYBEAN  
POVIDONE  
MINERAL OIL  
FD&C RED NO. 40  
FD&C BLUE NO. 2  
POLYETHYLENE GLYCOLS  
SODIUM ASCORBATE  
TOCOPHEROL  
TRICALCIUM PHOSPHATE  
C10-18 TRIGLYCERIDES  
GLYCERYL MONOSTEARATE  
TRIETHYL CITRATE  
SORBIC ACID  
ASCORBYL PALMITATE  
POLYSORBATE 80  
METHYLPARABEN  
PROPYLPARABEN  
Product Characteristics
Color purple Score 2 pieces
Shape OVAL Size 17mm
Flavor Imprint Code FOLET
Contains         
Packaging
# Item Code Package Description
1 30 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/28/2014
Part 2 of 2
Folet DHA 
docosahexaenoic acid (dha) capsule, liquid filled
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 350 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
METHACRYLIC ACID  
WATER  
POLYETHYLENE GLYCOLS  
TALC  
HYPROMELLOSES  
MINERAL OIL  
Product Characteristics
Color yellow Score no score
Shape OVAL Size 14mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 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 08/28/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/28/2014
Labeler - Pronova Corporation (111421496)
Revised: 09/2014
 
Pronova Corporation



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