Hfe

Hfe
SPL v3
SPL
SPL Set ID 7d508fdd-ba8b-07ec-e053-2991aa0a29ef
Route
ORAL
Published
Effective Date 2018-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dioscorea Villosa Root (4 [hp_X]) Oryctolagus Cuniculus Ovary (10 [hp_X]) Apis Mellifera (5 [hp_X]) Atropa Belladonna (6 [hp_X]) Black Cohosh (2 [hp_X]) Caulophyllum Thalictroides Root (8 [hp_X]) Chamaelirium Luteum Root Oryctolagus Cuniculus Adrenal Gland Viburnum Opulus Bark Gelsemium Sempervirens Root Magnesium Cation Oryctolagus Cuniculus Uterus
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-12-18

Description

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


Medication Information

Warnings and Precautions

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.

Indications and 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.

Dosage and 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.

Description

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

Section 34088-5

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

Section 50565-1

Keep out of reach of children.

Section 50566-9

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

Section 51727-6

Inactive ingredients

Ethanol (beet), purified water

Section 51945-4

NDC 62106-0623-0

HFE

HOMEOPATHIC PREPARATION

To help promote and maintain

female reproductive health.

Contains 31% Alcohol

1 fl oz (30 mL)

Section 53414-9

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

Section 55105-1

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.

Section 55106-9

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

Section 60561-8

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.


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 34088-5 (34088-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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

Section 51727-6 (51727-6)

Inactive ingredients

Ethanol (beet), purified water

Section 51945-4 (51945-4)

NDC 62106-0623-0

HFE

HOMEOPATHIC PREPARATION

To help promote and maintain

female reproductive health.

Contains 31% Alcohol

1 fl oz (30 mL)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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.

Section 55106-9 (55106-9)

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

Section 60561-8 (60561-8)

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.


Advanced Ingredient Data


Raw Label Data

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