Hfe Liquid
FDA Label NDC 62106-0623

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Hfe (NDC 62106-0623). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, overdosage, otc - stop use, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Otc - Pregnancy Or Breast Feeding

→ Overdosage

→ Otc - Stop Use

→ Other Safety Information

→ Inactive Ingredient

→ Dosage & Administration

→ Indications & Usage

→ Package Label.principal Display Panel

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

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.

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