Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID c0f80b84-0dd5-416b-abdf-8a0412e0b40b
Route
ORAL
Published
Effective Date 2025-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hops (3 [hp_X]) Passiflora Incarnata Flowering Top (12 [hp_X]) Valerian Ambrosia Artemisiifolia Arsenic Cation (3+) Coffea Arabica Seed, Roasted Lycopodium Clavatum Spore Strychnos Nux-vomica Seed Phosphoric Acid Silicon Dioxide
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-10-14
Description

Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Coffea Tosta 12X, Humulus Lupulus 3X, Lycopodium Clavatum 12X, Nux Vomica 12X, Passiflora Incarnata 3X, Phosphoricum Acidum 12X, Silicea 12X, Valeriana Officinalis 3X.

Purpose

Ambrosia Artemisiaefolia – difficulty sleeping,** Arsenicum Album - fatigue,** Coffea Tosta - sleeplessness,** Humulus Lupulus – nervous exhaustion,** Lycopodium Clavatum - irritability,** Nux Vomica - irritability,** Passiflora Incarnata – restless sleep,** Phosphoricum Acidum – fatigue,** Silicea - fatigue,** Valeriana Officinalis – tossing & turning** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Medication Information

Purpose

Ambrosia Artemisiaefolia – difficulty sleeping,** Arsenicum Album - fatigue,** Coffea Tosta - sleeplessness,** Humulus Lupulus – nervous exhaustion,** Lycopodium Clavatum - irritability,** Nux Vomica - irritability,** Passiflora Incarnata – restless sleep,** Phosphoricum Acidum – fatigue,** Silicea - fatigue,** Valeriana Officinalis – tossing & turning** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Coffea Tosta 12X, Humulus Lupulus 3X, Lycopodium Clavatum 12X, Nux Vomica 12X, Passiflora Incarnata 3X, Phosphoricum Acidum 12X, Silicea 12X, Valeriana Officinalis 3X.

Uses:

For temporary relief of fatigue, insomnia with restlessness of the legs, irritability, light sleep with drowsiness in the morning.**

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

Purpose:

Ambrosia Artemisiaefolia – difficulty sleeping,** Arsenicum Album - fatigue,** Coffea Tosta - sleeplessness,** Humulus Lupulus – nervous exhaustion,** Lycopodium Clavatum - irritability,** Nux Vomica - irritability,** Passiflora Incarnata – restless sleep,** Phosphoricum Acidum – fatigue,** Silicea - fatigue,** Valeriana Officinalis – tossing & turning**

**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:

Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Coffea Tosta 12X, Humulus Lupulus 3X, Lycopodium Clavatum 12X, Nux Vomica 12X, Passiflora Incarnata 3X, Phosphoricum Acidum 12X, Silicea 12X, Valeriana Officinalis 3X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

SOMINEZE

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, insomnia with restlessness of the legs, irritability, light sleep with drowsiness in the morning.**

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

Purpose: (PURPOSE:)

Ambrosia Artemisiaefolia – difficulty sleeping,** Arsenicum Album - fatigue,** Coffea Tosta - sleeplessness,** Humulus Lupulus – nervous exhaustion,** Lycopodium Clavatum - irritability,** Nux Vomica - irritability,** Passiflora Incarnata – restless sleep,** Phosphoricum Acidum – fatigue,** Silicea - fatigue,** Valeriana Officinalis – tossing & turning**

**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:)

Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Coffea Tosta 12X, Humulus Lupulus 3X, Lycopodium Clavatum 12X, Nux Vomica 12X, Passiflora Incarnata 3X, Phosphoricum Acidum 12X, Silicea 12X, Valeriana Officinalis 3X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

SOMINEZE

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: 2026-02-15T12:12:10.877518 · Updated: 2026-03-14T23:17:35.615715