Label: 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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated September 15, 2014

If you are a consumer or patient please visit this version.

  • 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.

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  • Dosage and Administration

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

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  • 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.

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  • 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.

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  • 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.

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  • INGREDIENTS AND APPEARANCE
    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 Item Code (Source) NDC:67555-153
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67555-153-30 1 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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BETA CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) BETA CAROTENE 2700 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 18 [iU]
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3.4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 40 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug
    FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 38 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 30 mg
    ZINC GLYCINATE (UNII: 681VJX72FE) (ZINC CATION - UNII:13S1S8SF37) ZINC GLYCINATE 10 mg
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 65 ug
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    GELATIN (UNII: 2G86QN327L)  
    SHELLAC (UNII: 46N107B71O)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    CROSPOVIDONE (UNII: 68401960MK)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TRIACETIN (UNII: XHX3C3X673)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    POVIDONE (UNII: FZ989GH94E)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SORBIC ACID (UNII: X045WJ989B)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color purple Score 2 pieces
    Shape OVAL Size 17mm
    Flavor Imprint Code FOLET
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 30 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
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 350 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    Color yellow Score no score
    Shape OVAL Size 14mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 30 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)
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