Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID 03ce1f50-6af5-4640-825f-67fcb25e76e6
Route
ORAL
Published
Effective Date 2025-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Angelica Archangelica Root (3 [hp_X]) American Ginseng (5 [hp_X]) Black Cohosh (12 [hp_X]) Goldenseal (15 [hp_X]) Anemone Pulsatilla Juniperus Sabina Leafy Twig Sepia Officinalis Juice Sulfuric Acid Lachesis Muta Venom
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-05-18

Description

Angelica Archangelica 3X, Aralia Quinquefolia 3X, Cimicifuga Racemosa 3X, Hydrastis Canadensis 3X, Pulsatilla 12X, Sabina 12X, Sepia 12X, Sulphuricum Acidum 12X, Lachesis Mutus 15X.

Purpose

Angelica Archangelica - nausea,** Aralia Quinquefolia – low back pain,** Cimicifuga Racemosa – minor back pain,** Hydrastis Canadensis - headache,** Pulsatilla - moodiness,** Sabina – hormone support,** Sepia – irregular menses,** Sulphuricum Acidum – fertility support,** Lachesis Mutus – headache** **Claims based on traditional homeopathic practice, not accepted medical evidencel. Not FDA evaluated.


Medication Information

Purpose

Angelica Archangelica - nausea,** Aralia Quinquefolia – low back pain,** Cimicifuga Racemosa – minor back pain,** Hydrastis Canadensis - headache,** Pulsatilla - moodiness,** Sabina – hormone support,** Sepia – irregular menses,** Sulphuricum Acidum – fertility support,** Lachesis Mutus – headache** **Claims based on traditional homeopathic practice, not accepted medical evidencel. Not FDA evaluated.

Description

Angelica Archangelica 3X, Aralia Quinquefolia 3X, Cimicifuga Racemosa 3X, Hydrastis Canadensis 3X, Pulsatilla 12X, Sabina 12X, Sepia 12X, Sulphuricum Acidum 12X, Lachesis Mutus 15X.

Uses:

For temporary relief of flushes of heat with attacks of perspiration, physical weakness with headaches, moodiness with symptoms ever-changing.

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

Purpose:

Angelica Archangelica - nausea,** Aralia Quinquefolia – low back pain,** Cimicifuga Racemosa – minor back pain,** Hydrastis Canadensis - headache,** Pulsatilla - moodiness,** Sabina – hormone support,** Sepia – irregular menses,** Sulphuricum Acidum – fertility support,** Lachesis Mutus – headache**

**Claims based on traditional homeopathic practice, not accepted medical evidencel. 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, Aralia Quinquefolia 3X, Cimicifuga Racemosa 3X, Hydrastis Canadensis 3X, Pulsatilla 12X, Sabina 12X, Sepia 12X, Sulphuricum Acidum 12X, Lachesis Mutus 15X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

MENOPAUSE

HOMEOPATHIC

1 fl. oz. (30mL)

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 flushes of heat with attacks of perspiration, physical weakness with headaches, moodiness with symptoms ever-changing.

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

Purpose: (PURPOSE:)

Angelica Archangelica - nausea,** Aralia Quinquefolia – low back pain,** Cimicifuga Racemosa – minor back pain,** Hydrastis Canadensis - headache,** Pulsatilla - moodiness,** Sabina – hormone support,** Sepia – irregular menses,** Sulphuricum Acidum – fertility support,** Lachesis Mutus – headache**

**Claims based on traditional homeopathic practice, not accepted medical evidencel. 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, Aralia Quinquefolia 3X, Cimicifuga Racemosa 3X, Hydrastis Canadensis 3X, Pulsatilla 12X, Sabina 12X, Sepia 12X, Sulphuricum Acidum 12X, Lachesis Mutus 15X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

MENOPAUSE

HOMEOPATHIC

1 fl. oz. (30mL)

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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