Label: 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
- NDC Code(s): 62106-0623-0
- Packager: Seroyal USA
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated July 22, 2021
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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 10XOryctolagus cuniculus (Rabbit) Adrenal Gland 10X
Oryctolagus cuniculus (Rabbit) Ovary 10XOryctolagus cuniculus (Rabbit) Uterus 10X
Viburnum opulus Bark 2X - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- OVERDOSAGE
- STOP USE
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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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.
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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
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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 liquidProduct 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)