The safety of Bendectin/Diclectin in the management of nausea and vomiting of pregnancy has been established by its use in many thousands of pregnant women”.A study was conducted to determine whether the combination drug of pyridoxine and doxylamine had an effect on the neurodevelopment of children exposed in utero. Results from this study observed no difference in intelligence quotient scores between children who were exposed to pyridoxine/doxylamine in utero and children who were not exposed. History
The combination of doxylamine and vitamin B6 was first introduced to the US market as Bendectin in 1956. At that time, Bendectin was a 3 ingredients prescription medication. The third one, dicyclomine, a Pregnancy Category B anticholinergic/antispasmodic, was omitted from the formulation starting in 1976 due to its lack of efficacy. : 317  Bendectin (doxylamine/vitamin B6) was voluntarily removed from the market in 1983 by its manufacturer, Merrell Dow Pharmaceuticals, following numerous lawsuits alleging that it caused birth defects, although an FDA panel concluded that no association between Bendectin and birth defects had been demonstrated. In litigation, Bendectin was implicated as the cause of various fetal malformations and problems including limb and other musculoskeletal deformities, facial and brain damage, defects of the respiratory, gastrointestinal, cardiovascular and genital-urinary systems, blood disorders and cancer. The most famous case involving the drug is Daubert v. Merrell Dow Pharmaceuticals (1993). These suits were led by celebrity plaintiff attorney Melvin Belli .
Herbal distillates, also known as floral waters, hydrosols, hydrolates, herbal waters, and essential waters, are aqueous products of hydrodistillation. They are colloidal suspensions of essential oils as well as water-soluble components obtained by steam distillation or hydrodistillation (a variant of steam distillation) from plants and herbs. These herbal distillates have uses as flavorings and cosmetics. Common herbal distillates for skincare include rose water, orange flower water, and witch hazel. Rosemary, oregano, and thyme are hydrosols that may be used in food manufacturing. Production
Herbal distillates are produced in the same or similar manner as essential oils. However, essential oils will float to the top of the distillate where it is removed, leaving behind the watery distillate. For this reason the term essential water is an apt description. In the past, these essential waters were often considered a byproduct of distillation, but are now considered an important co-product. The produced herbal waters are essentially diluted essential oils at less than 1% concentration (typically 0.02% to 0.05%). Several factors, such as temperature and an herbs growth cycle, impact the characteristics of a distillate, and therefore influence the timing of the distillation. Rosemary, for example, should be distilled in the peak of summer before it flowers. Usage
Distillates are used as flavorings, cosmetics and as herbal treatments. Herbal distillates are less concentrated than essential oils, possibly making them more suitable for some topical uses. Science
The science of distillation is based on the fact that different substances vaporise at different temperatures.