Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID 090c291e-50c7-4497-84cf-2cc9bc4d8a35
Route
ORAL
Published
Effective Date 2026-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Marsdenia Condurango Bark (1 [hp_X]) Hops (3 [hp_X]) Chaste Tree (6 [hp_X]) Caulophyllum Thalictroides Root (12 [hp_X]) Iris Versicolor Root (15 [hp_X]) Lilium Lancifolium Whole Flowering Asterias Rubens Apis Mellifera Fluoride Ion Conium Maculatum Flowering Top Strychnos Ignatii Seed Canis Lupus Familiaris Milk Lachesis Muta Venom Sepia Officinalis Juice Cyclamen Purpurascens Tuber
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-09-02

Description

Agnus Castus 3X, Apis Mellifica 12X, Asterias Rubens 6X, 12X, Calcarea Fluorica 12X, Caulophyllum Thalictroides 3X, Condurango MT, Conium Maculatum 12X, Cyclamen Europaeum 15X, Humulus Lupulus MT, Ignatia Amara 12X, Iris Versicolor 3X, Lac Caninum 12X, Lachesis Mutus 12X, Lilium Tigrinum 3X, Sepia 12X.

Purpose

Agnus Castus – female support,** Apis Mellifica - pain,** Asterias Rubens – breast soreness,** Calcarea Fluorica – hard knots in breast,** Caulophyllum Thalictroides – pain during menses,** Condurango – swollen breast,** Conium Maculatum – menstrual cramps,** Cyclamen Europaeum – female support,** Humulus Lupulus – hot flashes,** Ignatia Amara – premenstrual syndrome,** Iris Versicolor – lower abdomen pain,** Lac Caninum – breast discomfort,** Lachesis Mutus – hot flashes,** Lilium Tigrinum – irregular menses,** Sepia – irregular menstrual cycles** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Agnus Castus – female support,** Apis Mellifica - pain,** Asterias Rubens – breast soreness,** Calcarea Fluorica – hard knots in breast,** Caulophyllum Thalictroides – pain during menses,** Condurango – swollen breast,** Conium Maculatum – menstrual cramps,** Cyclamen Europaeum – female support,** Humulus Lupulus – hot flashes,** Ignatia Amara – premenstrual syndrome,** Iris Versicolor – lower abdomen pain,** Lac Caninum – breast discomfort,** Lachesis Mutus – hot flashes,** Lilium Tigrinum – irregular menses,** Sepia – irregular menstrual cycles** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Agnus Castus 3X, Apis Mellifica 12X, Asterias Rubens 6X, 12X, Calcarea Fluorica 12X, Caulophyllum Thalictroides 3X, Condurango MT, Conium Maculatum 12X, Cyclamen Europaeum 15X, Humulus Lupulus MT, Ignatia Amara 12X, Iris Versicolor 3X, Lac Caninum 12X, Lachesis Mutus 12X, Lilium Tigrinum 3X, Sepia 12X.

Uses:

For temporary relief of dysmenorrhea with severe ovarian pain; painful swollen breast before and during menses; menses early, profuse, black and clotted.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purpose:

Agnus Castus – female support,** Apis Mellifica - pain,** Asterias Rubens – breast soreness,** Calcarea Fluorica – hard knots in breast,** Caulophyllum Thalictroides – pain during menses,** Condurango – swollen breast,** Conium Maculatum – menstrual cramps,** Cyclamen Europaeum – female support,** Humulus Lupulus – hot flashes,** Ignatia Amara – premenstrual syndrome,** Iris Versicolor – lower abdomen pain,** Lac Caninum – breast discomfort,** Lachesis Mutus – hot flashes,** Lilium Tigrinum – irregular menses,** Sepia – irregular menstrual cycles**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

If pregnant or breast-feeding, ask a health care professional before use.

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

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

Directions:

• 10 drops orally, 3 times a day or as directed by a health care professional.

• Consult a health care professional for use in children under 12 years of age.

Active Ingredients:

Agnus Castus 3X, Apis Mellifica 12X, Asterias Rubens 6X, 12X, Calcarea Fluorica 12X, Caulophyllum Thalictroides 3X, Condurango MT, Conium Maculatum 12X, Cyclamen Europaeum 15X, Humulus Lupulus MT, Ignatia Amara 12X, Iris Versicolor 3X, Lac Caninum 12X, Lachesis Mutus 12X, Lilium Tigrinum 3X, Sepia 12X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

FEMALE TONIC

HOMEOPATHIC

2 fl. oz. (60 mL)

Keep Out of Reach of Children

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


Structured Label Content

Uses: (USES:)

For temporary relief of dysmenorrhea with severe ovarian pain; painful swollen breast before and during menses; menses early, profuse, black and clotted.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purpose: (PURPOSE:)

Agnus Castus – female support,** Apis Mellifica - pain,** Asterias Rubens – breast soreness,** Calcarea Fluorica – hard knots in breast,** Caulophyllum Thalictroides – pain during menses,** Condurango – swollen breast,** Conium Maculatum – menstrual cramps,** Cyclamen Europaeum – female support,** Humulus Lupulus – hot flashes,** Ignatia Amara – premenstrual syndrome,** Iris Versicolor – lower abdomen pain,** Lac Caninum – breast discomfort,** Lachesis Mutus – hot flashes,** Lilium Tigrinum – irregular menses,** Sepia – irregular menstrual cycles**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings: (WARNINGS:)

If pregnant or breast-feeding, ask a health care professional before use.

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

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

Directions: (DIRECTIONS:)

• 10 drops orally, 3 times a day or as directed by a health care professional.

• Consult a health care professional for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

Agnus Castus 3X, Apis Mellifica 12X, Asterias Rubens 6X, 12X, Calcarea Fluorica 12X, Caulophyllum Thalictroides 3X, Condurango MT, Conium Maculatum 12X, Cyclamen Europaeum 15X, Humulus Lupulus MT, Ignatia Amara 12X, Iris Versicolor 3X, Lac Caninum 12X, Lachesis Mutus 12X, Lilium Tigrinum 3X, Sepia 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

FEMALE TONIC

HOMEOPATHIC

2 fl. oz. (60 mL)

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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


Advanced Ingredient Data


Raw Label Data

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