The following Structured Product Label (SPL) was submitted to the FDA by Bioactive Nutritional, Inc. for the product Headache Tonic (NDC 43857-0261). 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.
Carduus Marianus 1X, Pyrethrum Parthenium 1X, Secale Cornutum 6X, Aconitum Napellus 12X, Belladonna 12X, Bryonia (Alba) 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Melilotus Officinalis 12X, Nux Vomica 12X, Sepia 12X, Spigelia Anthelmia 12X
For temporary relief of throbbing headache with muscular soreness of neck and shoulder pain and fullness, especially in the forehead, occiput and temples, and bursting, splitting headache.
For temporary relief of throbbing headache with muscular soreness of neck and shoulder pain and fullness, especially in the forehead, occiput and temples, and bursting, splitting headache.
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 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
Melbourne, FL 32935
For Nutritional Information write:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
BioActive Homeopathic
HEADACHE TONIC
2 FL OZ (60 ml)
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