HFE (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

HFE by

Drug Labeling and Warnings

HFE by is a Homeopathic medication manufactured, distributed, or labeled by Seroyal USA, SAN'UP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

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

OVERDOSAGE

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

STOP USE

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

OTHER SAFETY INFORMATION

Other information

Store in a cool, dry place.

Do not use if seal is missing or broken.

INACTIVE INGREDIENT

Inactive ingredients

Ethanol (beet), purified water

DOSAGE & 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.

INDICATIONS & USAGE

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.

PRINCIPAL DISPLAY PANEL

NDC: 62106-0623-0

HFE

HOMEOPATHIC PREPARATION

To help promote and maintain
female reproductive health.

Contains 31% Alcohol

1 fl oz (30 mL)

INGREDIENTS AND APPEARANCE

HFE 
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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62106-0623
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA ROOT - UNII:IWY3IWX2G8)	DIOSCOREA VILLOSA ROOT	4 [hp_X]  in 30 mL
ORYCTOLAGUS CUNICULUS OVARY (UNII: XA09528U2R) (ORYCTOLAGUS CUNICULUS OVARY - UNII:XA09528U2R)	ORYCTOLAGUS CUNICULUS OVARY	10 [hp_X]  in 30 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	5 [hp_X]  in 30 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	4 [hp_X]  in 30 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	6 [hp_X]  in 30 mL
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH)	CAULOPHYLLUM THALICTROIDES ROOT	4 [hp_X]  in 30 mL
CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U)	CHAMAELIRIUM LUTEUM ROOT	4 [hp_X]  in 30 mL
ORYCTOLAGUS CUNICULUS ADRENAL GLAND (UNII: QGY289M89Q) (ORYCTOLAGUS CUNICULUS ADRENAL GLAND - UNII:QGY289M89Q)	ORYCTOLAGUS CUNICULUS ADRENAL GLAND	10 [hp_X]  in 30 mL
VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805)	VIBURNUM OPULUS BARK	2 [hp_X]  in 30 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	8 [hp_X]  in 30 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	10 [hp_X]  in 30 mL
ORYCTOLAGUS CUNICULUS UTERUS (UNII: NQX84Z32G6) (ORYCTOLAGUS CUNICULUS UTERUS - UNII:NQX84Z32G6)	ORYCTOLAGUS CUNICULUS UTERUS	10 [hp_X]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62106-0623-0	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	12/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/18/2018

Labeler - Seroyal USA (018361118)

Establishment
Name	Address	ID/FEI	Business Operations
SAN'UP		401010287	manufacture(62106-0623)