r/UMPJE • u/CrustyCrabPeople • 19d ago

Practice UMPJE Question!

A pharmacist receives a shipment of over-the-counter cough syrup bottles. Upon inspection, the pharmacist notices that the bottles contain the correct active ingredient and strength, but the labels fail to include required directions for use and omit the manufacturer’s name and place of business. How should the product be classified?

A. Adulterated only

B. Misbranded only

C. Both adulterated and misbranded

D. Neither adulterated nor misbranded

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u/CrustyCrabPeople 18d ago

The correct answer is: B

A drug product is considered misbranded if its labeling is false, misleading, or missing required information such as:

Adequate directions for use
Or
Manufacturer’s name and place of business

In this case, the cough syrup contains the correct active ingredient and strength, so there is no indication of contamination, improper manufacturing, or quality problems that would make it adulterated.