Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID 0f0aea3f-95d2-4a81-8180-cf675eeb7f62
Route
ORAL
Published
Effective Date 2025-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Atropa Belladonna (30 [hp_X]) Lachesis Muta Venom Strychnos Nux-vomica Seed Anemone Pulsatilla Claviceps Purpurea Sclerotium Sepia Officinalis Juice Ustilago Maydis
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-09-11

Description

Belladonna 30X, Lachesis Mutus 30X, Nux Vomica 30X, Pulsatilla 30X, Secale Cornutum 30X, Sepia 30X, Ustilago Maidis 30X.

Purpose

Belladonna - fever,** Lachesis Mutus - headache,** Nux Vomica - stomach cramps,** Pulsatilla - PMS,** Secale Cornutum - painful menstruation,** Sepia - irregular menses,** Ustilago Maidis - heavy menstruation** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Belladonna - fever,** Lachesis Mutus - headache,** Nux Vomica - stomach cramps,** Pulsatilla - PMS,** Secale Cornutum - painful menstruation,** Sepia - irregular menses,** Ustilago Maidis - heavy menstruation** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Belladonna 30X, Lachesis Mutus 30X, Nux Vomica 30X, Pulsatilla 30X, Secale Cornutum 30X, Sepia 30X, Ustilago Maidis 30X.

Uses:

For temporary relief of mood swings, flushes of heat and physical weakness due to menopause.**

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

Purpose:

Belladonna - fever,** Lachesis Mutus - headache,** Nux Vomica - stomach cramps,** Pulsatilla - PMS,** Secale Cornutum - painful menstruation,** Sepia - irregular menses,** Ustilago Maidis - heavy menstruation**

**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:

Belladonna 30X, Lachesis Mutus 30X, Nux Vomica 30X, Pulsatilla 30X, Secale Cornutum 30X, Sepia 30X, Ustilago Maidis 30X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

MENOPAUSE HP

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 mood swings, flushes of heat and physical weakness due to menopause.**

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

Purpose: (PURPOSE:)

Belladonna - fever,** Lachesis Mutus - headache,** Nux Vomica - stomach cramps,** Pulsatilla - PMS,** Secale Cornutum - painful menstruation,** Sepia - irregular menses,** Ustilago Maidis - heavy menstruation**

**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:)

Belladonna 30X, Lachesis Mutus 30X, Nux Vomica 30X, Pulsatilla 30X, Secale Cornutum 30X, Sepia 30X, Ustilago Maidis 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

MENOPAUSE HP

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

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