Folet One

Manufacturer
Pronova Corporation
Effective date
2014-07-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:35:49

Label at a glance#

ProductFolet One
Active ingredientASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN, CHOLECALCIFEROL, IRON, MAGNESIUM, ZINC, DOCUSATE SODIUM, .ALPHA.-TOCOPHEROL, D-, PYRIDOXINE HYDROCHLORIDE, DOCONEXENT
Label structure9 sections

Dosage and administration

One softgel daily with or without food or as recommended by your healthcare provider.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Serving Size: 1 softgel  Servings per container: 30

                       Amount per Serving     %Daily Value

Vitamin C                18 mg                       30%

Vitamin D               250 IU                        63%

Vitamin E                 15 IU                         50%

Vitamin B6               30 mg                      2500%

Folate                       1 mg                        125%

Vitamin B-12             15 mcg                    250%

Iron                          38 mg                       194%

Zinc                           20 mg                       334%

Magnesium                15 mg                           4%

Docusate Sodium         25 mg                          *

DHA                             225 mg                         *

Description

SPL UNCLASSIFIED SECTION

Folet One is a prescription prenatal vitamin and mineral supplementation with DHA taken throughout pregnancy and during the postnatal period for both lactating and non-lactating mother. Folet One 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.

This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.

Warning:

SPL UNCLASSIFIED SECTION

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDRE. In case of accidental overdose, call a doctor or poison control center immediately.

Do Not Use

SPL UNCLASSIFIED SECTION

Do not use Folet One for individuals with a known hypersensitivity to any of the ingredients. Patients with hemochromatosis and hemosiderosis. The product is not for use in children under 12 years of age.

Caution:

SPL UNCLASSIFIED SECTION

This product contains 1 mg folic acid, the maximum safe Reference Daily Intake (RDI) amount for this nutrient. Folic Acid alone should not be used for individuals with pernicious anemia and other megaloblastic anemias where vitamin B-12 is deficient. Folic acid in amounts above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

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 bleeding times. Adminitration of Folet One should be avoided in patients taking anticoagulants.

Adverse Reactions

SPL UNCLASSIFIED SECTION

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

Directions for use:

SPL UNCLASSIFIED SECTION

One softgel daily with or without food or as recommended by your healthcare provider.

Other Information:

SPL UNCLASSIFIED SECTION

Folet One is supplied in child-resistant trade bottles of 30 softgels and sample bottles of 4 softgels. Optimum storage condition= 30 to 40% relative humidity and 59 to 86 degrees F (15-30 degrees C). Protect from extreme temperature. Freezing and excessive heat may damage softgels.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FoletOnelabelFoletOnelabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67555-154-302020-02-18C16284748780-19d75b9d0-1ba9-f424-e053-dadaa90a57cefa8470fb-6e36-4c5a-8b44-cc9965638bb5
67555-154-302020-01-31C16284748780-19d75b9d0-1ba9-f424-e053-dadaa90a57cefa8470fb-6e36-4c5a-8b44-cc9965638bb5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67555-154-30EA - Each67555-1540d706d4b-584a-4dde-b44f-68de27db196d12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROL, D-ACTIVE INGREDIENTN9PR3490H91
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0R1
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF411
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG2041
DOCONEXENTACTIVE INGREDIENTZAD9OKH9JC1
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA01
FOLIC ACIDACTIVE INGREDIENT935E97BOY81
IRONACTIVE INGREDIENTE1UOL152H71
MAGNESIUMACTIVE INGREDIENTI38ZP9992A1
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BV1
ZINCACTIVE INGREDIENTJ41CSQ7QDS1
.ALPHA.-TOCOPHEROL, D-ACTIVE MOIETYN9PR3490H91
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0R1
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF411
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2041
DOCONEXENTACTIVE MOIETYZAD9OKH9JC1
DOCUSATEACTIVE MOIETYM7P27195AG1
FOLIC ACIDACTIVE MOIETY935E97BOY81
IRONACTIVE MOIETYE1UOL152H71
MAGNESIUMACTIVE MOIETYI38ZP9992A1
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z1
ZINCACTIVE MOIETYJ41CSQ7QDS1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GELATININACTIVE INGREDIENT2G86QN327L1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
SOY PROTEININACTIVE INGREDIENTR44IWB3RN51
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
WATERINACTIVE INGREDIENT059QF0KO0R1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97F1

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67555-15467555-154-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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 4 · 239 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii candidate
37 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSOAP / TOPICAL1 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
GELATINGELATIN2G86QN327LPASTILLE / ORAL143 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAVENOUS20 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY / VAGINALNAExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED PELLETS / ORAL4.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
40 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
WHITE WAXWHITE WAX7G1J5DA97FCREAM / VAGINAL40 mgExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM, AUGMENTED / TOPICAL10 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAELIXIR / ORAL12.5 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAMUSCULAR16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FLOTION / TOPICAL1 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
15 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, EXTENDED RELEASE / ORAL239 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / ORAL34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / PERIODONTAL3.44 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAGUM, CHEWING / BUCCAL48 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRACAVITARY0.05 mlExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPDROPS / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
GELATINGELATIN2G86QN327LDROPS / NASAL50 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 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
fb5ae915-5d9b-49ef-b9bf-e6c3198681fbfa8470fb-6e36-4c5a-8b44-cc9965638bb52014-07-01Exact identifier
spl id: fb5ae915-5d9b-49ef-b9bf-e6c3198681fb
spl set id: fa8470fb-6e36-4c5a-8b44-cc9965638bb5

Reported adverse events (FAERS/openFDA)#

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