Drug Facts:

Drug Facts:
SPL v5
SPL
SPL Set ID 85304d4f-78b9-499e-8e1d-9202d9cde33d
Route
ORAL
Published
Effective Date 2025-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Angelica Archangelica Root (3 [hp_X]) Black Cohosh (6 [hp_X]) Fucus Vesiculosus (12 [hp_X]) Sus Scrofa Hypothalamus (15 [hp_X]) Magnesium Cation Sus Scrofa Ovary Pyridoxine Lycoperdon Utriforme Fruiting Body Copper Sepia Officinalis Juice Zinc Lachesis Muta Venom
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-07-14

Description

Angelica Archangelica 3X, Bovista 12X, Cimicifuga Racemosa 3X, Cuprum Metallicum 12X, Fucus Vesiculosus 3X, Hypothalamus Suis 6X, Lachesis Mutus 15X, Magnesium Gluconicum Dihydricum 6X, Oophorinum 6X, Pyridoxinum Hydrochloricum 6X, Sepia 12X, Zincum Metallicum 12X.

Purpose

Angelica Archangelica - nausea,** Bovista - itching,** Cimicifuga Racemosa – minor backpains,** Cuprum Metallicum - cramps,** Fucus Vesiculosus - headache,** Hypothalamus Suis - fatigue,** Lachesis Mutus - headache,** Magnesium Gluconicum Dihydricum – low energy,** Oophorinum – hot flashes,** Pyridoxinum Hydrochloricum - antioxidant,** Sepia – irregular menstrual cycles,** Zincum Metallicum – tiredness** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA Evaluated.


Medication Information

Purpose

Angelica Archangelica - nausea,** Bovista - itching,** Cimicifuga Racemosa – minor backpains,** Cuprum Metallicum - cramps,** Fucus Vesiculosus - headache,** Hypothalamus Suis - fatigue,** Lachesis Mutus - headache,** Magnesium Gluconicum Dihydricum – low energy,** Oophorinum – hot flashes,** Pyridoxinum Hydrochloricum - antioxidant,** Sepia – irregular menstrual cycles,** Zincum Metallicum – tiredness** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA Evaluated.

Description

Angelica Archangelica 3X, Bovista 12X, Cimicifuga Racemosa 3X, Cuprum Metallicum 12X, Fucus Vesiculosus 3X, Hypothalamus Suis 6X, Lachesis Mutus 15X, Magnesium Gluconicum Dihydricum 6X, Oophorinum 6X, Pyridoxinum Hydrochloricum 6X, Sepia 12X, Zincum Metallicum 12X.

Uses:

For temporary relief of fatigue, feelings or anxiety before menstruation, tender breasts, flushes of heat, and headaches.

Purpose:

Angelica Archangelica - nausea,** Bovista - itching,** Cimicifuga Racemosa – minor backpains,** Cuprum Metallicum - cramps,** Fucus Vesiculosus - headache,** Hypothalamus Suis - fatigue,** Lachesis Mutus - headache,** Magnesium Gluconicum Dihydricum – low energy,** Oophorinum – hot flashes,** Pyridoxinum Hydrochloricum - antioxidant,** Sepia – irregular menstrual cycles,** Zincum Metallicum – tiredness**

**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.

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

Active Ingredients:

Angelica Archangelica 3X, Bovista 12X, Cimicifuga Racemosa 3X, Cuprum Metallicum 12X, Fucus Vesiculosus 3X, Hypothalamus Suis 6X, Lachesis Mutus 15X, Magnesium Gluconicum Dihydricum 6X, Oophorinum 6X, Pyridoxinum Hydrochloricum 6X, Sepia 12X, Zincum Metallicum 12X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

PMS

HOMEOPATHIC

1 FL OZ (30 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 fatigue, feelings or anxiety before menstruation, tender breasts, flushes of heat, and headaches.

Purpose: (PURPOSE:)

Angelica Archangelica - nausea,** Bovista - itching,** Cimicifuga Racemosa – minor backpains,** Cuprum Metallicum - cramps,** Fucus Vesiculosus - headache,** Hypothalamus Suis - fatigue,** Lachesis Mutus - headache,** Magnesium Gluconicum Dihydricum – low energy,** Oophorinum – hot flashes,** Pyridoxinum Hydrochloricum - antioxidant,** Sepia – irregular menstrual cycles,** Zincum Metallicum – tiredness**

**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.

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Angelica Archangelica 3X, Bovista 12X, Cimicifuga Racemosa 3X, Cuprum Metallicum 12X, Fucus Vesiculosus 3X, Hypothalamus Suis 6X, Lachesis Mutus 15X, Magnesium Gluconicum Dihydricum 6X, Oophorinum 6X, Pyridoxinum Hydrochloricum 6X, Sepia 12X, Zincum Metallicum 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

PMS

HOMEOPATHIC

1 FL OZ (30 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

All Sections (JSON)