Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID 141fb6b7-08d9-4b57-bafd-ba5c8f98914e
Route
ORAL
Published
Effective Date 2026-03-11
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 Oyster Shell Calcium Carbonate, Crude Coffea Arabica Seed, Roasted Strychnos Ignatii Seed Phosphate Ion Moschus Moschiferus Musk Sac Resin Strychnos Nux-vomica Seed Phosphorus Pulsatilla Pratensis Whole
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-02-19

Description

Calcarea Carbonica 12X, Coffea Tosta 12X, Humulus Lupulus 3X, Ignatia Amara 12X, Kali Phosphoricum 12X, Moschus 12X, Nux Vomica 12X, Passiflora Incarnata 3X, Phosphorus 12X, Pulsatilla 12X, Valeriana Officinalis 3X.

Purpose

Calcarea Carbonica - cramps,** Coffea Tosta – overactive thoughts,** Humulus Lupulus - overexcitement,** Ignatia Amara - grief,** Kali Phosphoricum - fatigue,** Moschus - phobias,** Nux Vomica - stress,** Passiflora Incarnata - worries,** Phosphorus – mental exhaustion,** Pulsatilla – night time calmative,** Valeriana Officinalis – irritability** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Calcarea Carbonica - cramps,** Coffea Tosta – overactive thoughts,** Humulus Lupulus - overexcitement,** Ignatia Amara - grief,** Kali Phosphoricum - fatigue,** Moschus - phobias,** Nux Vomica - stress,** Passiflora Incarnata - worries,** Phosphorus – mental exhaustion,** Pulsatilla – night time calmative,** Valeriana Officinalis – irritability** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Calcarea Carbonica 12X, Coffea Tosta 12X, Humulus Lupulus 3X, Ignatia Amara 12X, Kali Phosphoricum 12X, Moschus 12X, Nux Vomica 12X, Passiflora Incarnata 3X, Phosphorus 12X, Pulsatilla 12X, Valeriana Officinalis 3X.

Uses:

For temporary relief of anxiety and stress.**

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

Purpose:

Calcarea Carbonica - cramps,** Coffea Tosta – overactive thoughts,** Humulus Lupulus - overexcitement,** Ignatia Amara - grief,** Kali Phosphoricum - fatigue,** Moschus - phobias,** Nux Vomica - stress,** Passiflora Incarnata - worries,** Phosphorus – mental exhaustion,** Pulsatilla – night time calmative,** Valeriana Officinalis – irritability**

**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:

Calcarea Carbonica 12X, Coffea Tosta 12X, Humulus Lupulus 3X, Ignatia Amara 12X, Kali Phosphoricum 12X, Moschus 12X, Nux Vomica 12X, Passiflora Incarnata 3X, Phosphorus 12X, Pulsatilla 12X, Valeriana Officinalis 3X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

RELAXOFORCE

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 anxiety and stress.**

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

Purpose: (PURPOSE:)

Calcarea Carbonica - cramps,** Coffea Tosta – overactive thoughts,** Humulus Lupulus - overexcitement,** Ignatia Amara - grief,** Kali Phosphoricum - fatigue,** Moschus - phobias,** Nux Vomica - stress,** Passiflora Incarnata - worries,** Phosphorus – mental exhaustion,** Pulsatilla – night time calmative,** Valeriana Officinalis – irritability**

**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:)

Calcarea Carbonica 12X, Coffea Tosta 12X, Humulus Lupulus 3X, Ignatia Amara 12X, Kali Phosphoricum 12X, Moschus 12X, Nux Vomica 12X, Passiflora Incarnata 3X, Phosphorus 12X, Pulsatilla 12X, Valeriana Officinalis 3X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

RELAXOFORCE

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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