Because Paregoric has been around for more than 100 years, it was "grandfathered" in by the FDA.....in other words, the manufacturer didn't have to submit any data showing that it was safe and effective. The FDA has been cracking down on grandfathered drugs and a few years ago it required the manufacturers of paregoric to submit data showing that it is safe and effective. To date, I don't believe any manufacturer has done so, so it is no longer available.
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