Headache Liquid
FDA Label NDC 43857-0805

9 label sections · Submitted to the FDA by Bioactive Nutritionals, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bioactive Nutritionals, Inc. for the product Headache (NDC 43857-0805). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients:, purpose:, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Allium Cepa 12X, Belladonna 12X, Bryonia (Alba) 12X, Cimicifuga Racemosa 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Lachesis Mutus 12X, Magnesia Phosphorica 12X, Melilotus Officinalis 3X, Nux Vomica 12X, Sanguinaria Canadensis 12X, Silicea 12X, Spigelia Anthelmia 6X.

Purpose:

Allium Cepa - fatigue,** Belladonna – muscle pains,** Bryonia (Alba) – minor pains,** Cimicifuga Racemosa - headache,** Gelsemium Sempervirens - headache,** Glonoinum – muscle cramps,** Lachesis Mutus - headache,** Magnesia Phosphorica – muscle cramps,** Melilotus Officinalis - exhaustion,** Nux Vomica – joint support,** Sanguinaria Canadensis - headache,** Silicea – muscle cramps,** Spigelia Anthelmia – antioxidant**

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

Uses:

For temporary relief of headache with muscular soreness of neck and shoulders; heaviness of the head; fullness all over the head, and pain as if  and around the head.**

**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.

Keep Out Of Reach Of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

• 10 drops orally, 3 times a day or as directed by a health care professional.

• Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Questions:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

1-800-288-9525

Package Label Display:

BIOActive Nutritional

HEADACHE

HOMEOPATHIC

1 fl. oz. (30 mL)

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