Drug Facts:

Drug Facts:
SPL v7
SPL
SPL Set ID 410861ef-3f55-4a09-888e-2123b820f878
Route
ORAL
Published
Effective Date 2025-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Melatonin (6 [hp_X]) Nadide (8 [hp_X]) Niacin Pyridoxine Zinc Cation Sus Scrofa Pituitary Gland Sus Scrofa Hypothalamus Lithium Cation Carbonate Ion Sus Scrofa Pineal Gland
Inactive Ingredients
Citric Acid Monohydrate Water Glycerin Sodium Benzoate Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2012-05-04
Description

Hypophysis Suis 8X, Hypothalamus 8X, Lithium Carbonicum 8X, Magnesia Carbonica 8X, Melatonin 6X, Nadidum 6X, Niacin 6X, Pineal 8X, Pyridoxinum Hydrochloricum 6X, Zincum Sulphuricum 6X.

Purpose

Hypophysis Suis – heavy menses,** Hypothalamus – hormonal regulation,** Lithium Carbonicum - irritability,** Magnesia Carbonica – trouble sleeping,** Melatonin – difficulty sleeping,** Nadidum - fatigue,** Niacin - antioxidant,** Pineal – hormonal regulation,** Pyridoxinum Hydrochloricum – night sweats,** Zincum Sulphuricum – abdomen pain** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Medication Information

Purpose

Hypophysis Suis – heavy menses,** Hypothalamus – hormonal regulation,** Lithium Carbonicum - irritability,** Magnesia Carbonica – trouble sleeping,** Melatonin – difficulty sleeping,** Nadidum - fatigue,** Niacin - antioxidant,** Pineal – hormonal regulation,** Pyridoxinum Hydrochloricum – night sweats,** Zincum Sulphuricum – abdomen pain** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Hypophysis Suis 8X, Hypothalamus 8X, Lithium Carbonicum 8X, Magnesia Carbonica 8X, Melatonin 6X, Nadidum 6X, Niacin 6X, Pineal 8X, Pyridoxinum Hydrochloricum 6X, Zincum Sulphuricum 6X.

Uses:

For temporary relief of imbalances in menstruation and ovulation, insomnia, dysmenorrhea and imbalance in menstrual cycle.**

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

Purpose:

Hypophysis Suis – heavy menses,** Hypothalamus – hormonal regulation,** Lithium Carbonicum - irritability,** Magnesia Carbonica – trouble sleeping,** Melatonin – difficulty sleeping,** Nadidum - fatigue,** Niacin - antioxidant,** Pineal – hormonal regulation,** Pyridoxinum Hydrochloricum – night sweats,** Zincum Sulphuricum – abdomen pain**

**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:

• Three sprays per day.

• Hold in mouth for two minutes.

Active Ingredients:

Hypophysis Suis 8X, Hypothalamus 8X, Lithium Carbonicum 8X, Magnesia Carbonica 8X, Melatonin 6X, Nadidum 6X, Niacin 6X, Pineal 8X, Pyridoxinum Hydrochloricum 6X, Zincum Sulphuricum 6X.

Inactive Ingredients:

Citric Acid, Demineralized Water, Ethanol 0.32%, Glycerin, Sodium Benzoate.

Package Label Display:

BIOActive Nutritional

MELATONIN FORTE

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 imbalances in menstruation and ovulation, insomnia, dysmenorrhea and imbalance in menstrual cycle.**

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

Purpose: (PURPOSE:)

Hypophysis Suis – heavy menses,** Hypothalamus – hormonal regulation,** Lithium Carbonicum - irritability,** Magnesia Carbonica – trouble sleeping,** Melatonin – difficulty sleeping,** Nadidum - fatigue,** Niacin - antioxidant,** Pineal – hormonal regulation,** Pyridoxinum Hydrochloricum – night sweats,** Zincum Sulphuricum – abdomen pain**

**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:)

• Three sprays per day.

• Hold in mouth for two minutes.

Active Ingredients: (ACTIVE INGREDIENTS:)

Hypophysis Suis 8X, Hypothalamus 8X, Lithium Carbonicum 8X, Magnesia Carbonica 8X, Melatonin 6X, Nadidum 6X, Niacin 6X, Pineal 8X, Pyridoxinum Hydrochloricum 6X, Zincum Sulphuricum 6X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Citric Acid, Demineralized Water, Ethanol 0.32%, Glycerin, Sodium Benzoate.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

MELATONIN FORTE

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:02.854857 · Updated: 2026-03-14T23:17:22.861881