The following Structured Product Label (SPL) was submitted to the FDA by Bioactive Nutritionals, Inc. for the product Headache (NDC 43857-0488). 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:, indications:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Melilotus Officinalis 9X, Spigelia Anthelmia 6X, Allium Cepa 12X, Belladonna 12X, Bryonia (Alba) 12X, Cimicifuga Racemosa 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Magnesia Phosphorica 12X, Nux Vomica 12X, Sanguinaria Canadensis 12X, Silicea 12X, Tarentula Cubensis 12X.
For temporary relief of headache with muscular soreness of neck and shoulders, heaviness of the head, fullness all over the head, pain as if a band around the head.
For temporary relief of headache with muscular soreness of neck and shoulders, heaviness of the head, fullness all over the head, pain as if a band around the head.
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.
10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
Demineralized Water, 25% Ethanol
Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com
BIOActive Nutritional
HEADACHE
HOMEOPATHIC
1 FL OZ (30 ml)
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