FDA Label for Hfe
View Indications, Usage & Precautions
Hfe Product Label
The following document was submitted to the FDA by the labeler of this product Seroyal Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - 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
Otc - 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - 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.
Otc - 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.
Package Label.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)
* Please review the disclaimer below.