HFE

Manufacturer
Seroyal USA | SAN'UP
Effective date
2021-07-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:14:45

Label at a glance#

ProductHFE
Active ingredientDIOSCOREA VILLOSA ROOT, ORYCTOLAGUS CUNICULUS OVARY, APIS MELLIFERA, ATROPA BELLADONNA, BLACK COHOSH, CAULOPHYLLUM THALICTROIDES ROOT, CHAMAELIRIUM LUTEUM ROOT, ORYCTOLAGUS CUNICULUS ADRENAL GLAND, VIBURNUM OPULUS BARK, GELSEMIUM SEMPERVIRENS ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, ORYCTOLAGUS CUNICULUS UTERUS
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Each drop contains:
Apis mellifica 5X
Belladonna Whole Plant 4X
(< 10-6 % alkaloids, calculated)
Caulophyllum thalictroides Underground Parts 4X
Cimicifuga racemosa Root/Rhizome 6X
Dioscorea villosa Underground Parts 4X
Gelsemium sempervirens Root 8X
Helonias dioica Root/Rhizome 4X
Magnesia phosphorica 10X

Oryctolagus cuniculus (Rabbit) Adrenal Gland 10X
Oryctolagus cuniculus (Rabbit) Ovary 10X

Oryctolagus cuniculus (Rabbit) Uterus 10X
Viburnum opulus Bark 2X

OTC - PURPOSE SECTION

Uses

Helps promote and maintain general female reproductive health.
Product 'Uses' are based on Homeopathic Materia Medica and have not been clinically tested. These 'Uses' have not been evaluated by the Food and Drug Administration.

WARNINGS SECTION

Warnings
Stop use and ask a doctor if symptoms persist or worsen.
If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist or worsen.

OTHER SAFETY INFORMATION

Other information

Store in a cool, dry place.

Use only if safety seal is intact

Contents may not fill package in order to accomodate required labelling. Please rely on stated quantity.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Ethanol (beet), purified water

DOSAGE & ADMINISTRATION SECTION

Directions

To be taken 20 minutes away from food. Place drops directly under the tongue or into ¼ oz of water.

Adults and adolescents (12 years and older): Take 10 drops two to three times daily or as recommended by your healthcare practitioner.

Children (under 12 years): Take under the direction of your healthcare practitioner.

INDICATIONS & USAGE SECTION

Uses

Helps promote and maintain general female reproductive health.
Product 'Uses' are based on Homeopathic Materia Medica and have not been clinically tested. These 'Uses' have not been evaluated by the Food and Drug Administration.

Directions

To be taken 20 minutes away from food. Place drops directly under the tongue or into ¼ oz of water.

Adults and adolescents (12 years and older): Take 10 drops two to three times daily or as recommended by your healthcare practitioner.

Children (under 12 years): Take under the direction of your healthcare practitioner.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

62106-0623-062106-0623-0

NDC 62106-0623-0

HFE

HOMEOPATHIC PREPARATION

To help promote and maintain
female reproductive health.

Contains 31% Alcohol

1 fl oz (30 mL)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-0623-0HFE30 mL in 1 BOTTLE, GLASSLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-0623HFE (APIS MELLIFICA, BELLADONNA, CAULOPHYLLUM THALICTROIDES, CIMICIFUGA RACEMOSA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, HELONIAS DIOICA, MAGNESIA PHOSPHORICA, ORYCTOLAGUS CUNICULUS (RABBIT) ADRENAL GLAND, ORYCTOLAGUS CUNICULUS (RABBIT) OVARY, ORYCTOLAGUS CUNICULUS (RABBIT) UTERUS, VIBURNUM OPULUS) LIQUID [SEROYAL USA]3Current NDC, Legacy NDC, 1 package rows20210724_7d508fdd-ba8b-07ec-e053-2991aa0a29ef.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62106-062362106-0623-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

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
HFEAPIS MELLIFICA, BELLADONNA, CAULOPHYLLUM THALICTROIDES, CIMICIFUGA RACEMOSA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, HELONIAS DIOICA, MAGNESIA PHOSPHORICA, ORYCTOLAGUS CUNICULUS (RABBIT) ADRENAL GLAND, ORYCTOLAGUS CUNICULUS (RABBIT) OVARY, ORYCTOLAGUS CUNICULUS (RABBIT) UTERUS, VIBURNUM OPULUSSeroyal USA7d508fdd-ba8b-07ec-e053-2991aa0a29ef2021-07-22WarningsExact identifier
ndc (package): 62106-0623-0
ndc (product): 62106-0623
ndc11 (package): 62106062300
spl id: c7c0766c-5fa4-95e0-e053-2995a90ac48f
spl set id: 7d508fdd-ba8b-07ec-e053-2991aa0a29ef

Reported adverse events (FAERS/openFDA)#

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