Folet DHA

Manufacturer
Pronova Corporation
Effective date
2020-02-18
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:40:36

Label at a glance#

ProductFolet DHA
Active ingredientBETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, FERROUS BISGLYCINATE, MAGNESIUM OXIDE, ZINC GLYCINATE, SELENIUM, DOCUSATE SODIUM, DOCONEXENT
Label structure6 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

Contraindications

CONTRAINDICATIONS SECTION

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 AND PRECAUTIONS SECTION

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

ADVERSE REACTIONS SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FoletDHAFoletDHA

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67555-153-302020-02-18C16284748780-19d75b9cf-eff6-f424-e053-dadaa90a57ce19df5244-1a40-4f9e-af28-e2a90d996566
67555-153-302020-01-31C16284748780-19d75b9cf-eff6-f424-e053-dadaa90a57ce19df5244-1a40-4f9e-af28-e2a90d996566

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67555-153-30EA - Each67555-1530c2305ee-2450-4881-b63e-5a4392d9f8c312014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROL ACETATE, D-ACTIVE INGREDIENTA7E6112E4N1
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0R1
BETA CAROTENEACTIVE INGREDIENT01YAE03M7J1
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF411
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG2041
DOCONEXENTACTIVE INGREDIENTZAD9OKH9JC1
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA01
FERROUS BISGLYCINATEACTIVE INGREDIENTSFW1D987QV1
FOLIC ACIDACTIVE INGREDIENT935E97BOY81
MAGNESIUM OXIDEACTIVE INGREDIENT3A3U0GI71G1
NIACINAMIDEACTIVE INGREDIENT25X51I8RD41
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BV1
RIBOFLAVINACTIVE INGREDIENTTLM2976OFR1
SELENIUMACTIVE INGREDIENTH6241UJ22B1
THIAMINE HYDROCHLORIDEACTIVE INGREDIENTM572600E5P1
ZINC GLYCINATEACTIVE INGREDIENT681VJX72FE1
.ALPHA.-TOCOPHEROL, D-ACTIVE MOIETYN9PR3490H91
.BETA.-CAROTENEACTIVE MOIETY01YAE03M7J1
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0R1
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF411
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2041
DOCONEXENTACTIVE MOIETYZAD9OKH9JC1
DOCUSATEACTIVE MOIETYM7P27195AG1
FERROUS CATIONACTIVE MOIETYGW89581OWR1
FOLIC ACIDACTIVE MOIETY935E97BOY81
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
NIACINAMIDEACTIVE MOIETY25X51I8RD41
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z1
RIBOFLAVINACTIVE MOIETYTLM2976OFR1
SELENIUMACTIVE MOIETYH6241UJ22B1
THIAMINE IONACTIVE MOIETY4ABT0J945J1
ZINC CATIONACTIVE MOIETY13S1S8SF371
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N1
C10-18 TRIGLYCERIDESINACTIVE INGREDIENT43AGM4PHPI1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92J1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
CROSPOVIDONEINACTIVE INGREDIENT68401960MK1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQK1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GELATININACTIVE INGREDIENT2G86QN327L1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G86561
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
POVIDONEINACTIVE INGREDIENTFZ989GH94E1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SHELLACINACTIVE INGREDIENT46N107B71O1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM ASCORBATEINACTIVE INGREDIENTS033EH83591
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B1
SOYBEANINACTIVE INGREDIENTL7HT8F1ZOD1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
TRIACETININACTIVE INGREDIENTXHX3C3X6731
TRICALCIUM PHOSPHATEINACTIVE INGREDIENTK4C08XP6661
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UM1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 65 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67555-15367555-153-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 59 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 17 · 1,017 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GELATINGELATIN2G86QN327LTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii candidate
19 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMTABLET, ORALLY DISINTEGRATING / ORAL17 mgExact identifier — unii candidate
19 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, EXTENDED RELEASE / ORAL239 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
40 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSUSPENSION / ORAL705 mgExact identifier — unii candidate
42 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / ORAL46 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPASTILLE / ORAL143 mgExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPOWDER / ORALNAExact identifier — unii candidate
68 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET / SUBLINGUAL24 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PERIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48PELLET / ORAL162 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii candidate
30 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii candidate
39 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, FOR SUSPENSION / ORAL296 mgExact identifier — unii candidate
35 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
30 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMSUSPENSION, EXTENDED RELEASE / ORAL5 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii candidate
35 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NCREAM / TOPICAL0.02 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii candidate
28 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, EXTENDED RELEASE / ORAL184 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL357 mgExact identifier — unii candidate
35 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48SUSPENSION / ORAL150 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / RECTAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii candidate
22 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / SUBCUTANEOUS16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLIQUID / INTRAVENOUS720 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / BUCCAL0.01 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED / ORAL0.04 mgExact identifier — unii candidate
78 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, EXTENDED RELEASE / ORAL213.24 mgExact identifier — unii candidate
13 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, COATED / ORAL0.1 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LIQUID / TOPICAL1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, CHEWABLE / ORAL0.14 mgExact identifier — unii candidate
68 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCONCENTRATE / ORAL2.5 mg/5mlExact identifier — unii candidate
68 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SOLUTION / ORAL280 mgExact identifier — unii candidate
49 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b2ade83e-2dee-43e2-be8f-2e0a39057bba19df5244-1a40-4f9e-af28-e2a90d9965662014-09-15Warnings, Adverse reactionsExact identifier
spl set id: 19df5244-1a40-4f9e-af28-e2a90d996566

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.