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 
Seroyal USA

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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HFE

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

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
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.

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

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

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

Other information

Store in a cool, dry place.

Do not use if seal is missing or broken.

Inactive ingredients

Ethanol (beet), purified water

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.

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.

62106-0623

NDC 62106-0623-0

HFE

HOMEOPATHIC PREPARATION

To help promote and maintain
female reproductive health.

Contains 31% Alcohol

1 fl oz (30 mL)

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-0623
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA ROOT - UNII:IWY3IWX2G8) DIOSCOREA VILLOSA ROOT4 [hp_X]  in 30 mL
ORYCTOLAGUS CUNICULUS OVARY (UNII: XA09528U2R) (ORYCTOLAGUS CUNICULUS OVARY - UNII:XA09528U2R) ORYCTOLAGUS CUNICULUS OVARY10 [hp_X]  in 30 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA5 [hp_X]  in 30 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA4 [hp_X]  in 30 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH6 [hp_X]  in 30 mL
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT4 [hp_X]  in 30 mL
CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT4 [hp_X]  in 30 mL
ORYCTOLAGUS CUNICULUS ADRENAL GLAND (UNII: QGY289M89Q) (ORYCTOLAGUS CUNICULUS ADRENAL GLAND - UNII:QGY289M89Q) ORYCTOLAGUS CUNICULUS ADRENAL GLAND10 [hp_X]  in 30 mL
VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK2 [hp_X]  in 30 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT8 [hp_X]  in 30 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE10 [hp_X]  in 30 mL
ORYCTOLAGUS CUNICULUS UTERUS (UNII: NQX84Z32G6) (ORYCTOLAGUS CUNICULUS UTERUS - UNII:NQX84Z32G6) ORYCTOLAGUS CUNICULUS UTERUS10 [hp_X]  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62106-0623-030 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/18/2018
Labeler - Seroyal USA (018361118)
Establishment
NameAddressID/FEIBusiness Operations
SAN'UP401010287manufacture(62106-0623)

Revised: 12/2019
Document Id: 9a115116-62d9-7bd3-e053-2995a90ac79c
Set id: 7d508fdd-ba8b-07ec-e053-2991aa0a29ef
Version: 2
Effective Time: 20191219
 
Seroyal USA