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Boiron is a leading manufacturer of homeopathic medicines. All our homeopathic medicines
are made according to strict pharmaceutical and regulatory requirements. To make
our medicines more reliable, our preparation techniques combine a respect for tradition
with technological innovations.
FDA Regulations, Manufacturing Standards and Labeling
Since the passing of The Federal Food, Drug, and Cosmetic Act in 1938, the Food
and Drug Administration (FDA) has regulated homeopathic medicines as drugs. To be
accepted as a homeopathic medicine by the FDA, product ingredients must be identified
in the Homeopathic Pharmacopoeia of the United States (HPUS) or generally accepted
as homeopathic under the principles of homeopathy.
All Boiron homeopathic medicines are manufactured according to the highest standards,
complying with specifications of the HPUS, as well as Good Manufacturing Practices
(GMP).
Being regulated as a drug (as opposed to a food or dietary supplement) ensures that
homeopathic medicines adhere to drug labeling specifications. Like conventional
over-the-counter (OTC) drugs, packaging for homeopathic medicines must state (1)
specific diseases, ailments or symptoms for which the product is to be used, (2)
the concentration of active substance or substances contained therein, (3) the recommended
dosage and (4) the mode of application.
These clear specifications simplify choices for consumers and make guidance easier
for physicians, pharmacists and retailers.
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Sedalia® relieves stress-related problems such as short tern management of anxiety and nervousness, without affecting patient alertness or causing drowsiness. No known side effects, does not interfere with operation of machinery or mask underlying medical conditions.
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