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Folet DHA

Generic name: prenatal vitamin and mineral supplement
Dosage form: capsule, liquid filled

Medically reviewed by Drugs.com. Last updated on Aug 23, 2021.

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)
Pronova Corporation

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