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 
Pronova Corporation

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.

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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.

FoletDHA

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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67555-153
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67555-153-301 in 1 PACKAGE08/28/201403/15/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 
Part 21 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETA CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) BETA CAROTENE2700 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [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 HYDROCHLORIDE3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE40 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION38 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE30 mg
ZINC GLYCINATE (UNII: 681VJX72FE) (ZINC CATION - UNII:13S1S8SF37) ZINC GLYCINATE10 mg
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM65 ug
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
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: 2S7830E561)  
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 GLYCOL, UNSPECIFIED (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
ColorpurpleScore2 pieces
ShapeOVALSize17mm
FlavorImprint Code FOLET
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/28/201403/15/2017
Part 2 of 2
FOLET DHA 
docosahexaenoic acid (dha) capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT350 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize14mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/28/201403/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/28/201403/15/2017
Labeler - Pronova Corporation (111421496)

Revised: 2/2020
 
Pronova Corporation