Pancold A elicits FDA warning
This article was originally published in The Tan Sheet
Executive SummaryB&A Health Products' multi-symptom relief liquid OTC is an unapproved new drug because it does not conform with the final monograph for Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Drug Products. The agency says Pancold A does not satisfy monograph requirements because it includes noncompliant ingredients, such as anhydrous caffeine and di-methylephedrine hydrochloride, according to an Aug. 19 letter to the Santa Fe Spring, Calif., firm. FDA also says several indications contravene the monograph, including a claim the product is a "sneeze suppressant." Finally, FDA warns, the drug's packaging does not bear the Drug Facts labeling required of OTC drugs
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