Laudanum of opium tincture prevails today only because opium tincture was sold prior to the Federal Food, Drug & Cosmetic Act of 1938. Its "grandfathered" status protects opium tincture from being required to undergo strict FDA drug reviews and subsequent approval processes. However, the FDA closely monitors the labeling of opium tincture. Bottles of opium tincture are required by the FDA to bear a bright red "POISON" label given the potency of the drug and the potential for overdose (see discussion about confusion with Paregoric below). Despite opium tincture being an "unapproved drug" as discussed above, a search of FDA's website
Concomitant drug Concomitant drug Concomitant drugs are two or more drugs used or given at or almost at the same time (one after the other, on the same day, etc.). The term has two contextual uses: as used in medicine or as used in drug abuse. This designation is used when medicinal drugs are given either at the same time or almost at the same time. This is often the case in medicine. Chemotherapy for cancer applies as an example. The standard of care (sometimes also called the "gold standard") for the adjuvant treatment of stage III colon cancer is the FOLFOX