If 300 mg of Codeine powder is mixed with 3250 mg of Acetaminophen and made into 10 capsules of 355 mg each, how are these capsules classified?

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The classification of the capsules in this scenario hinges upon the content of codeine in combination with acetaminophen. In the United States, drug schedules are determined based on the potential for abuse, medical use, and safety.

In this case, the primary active ingredient is codeine, which is classified as a narcotic and has varying classifications depending on its formulation. Codeine is found in the Controlled Substances Act schedules:

  • Schedule II (C2) indicates drugs with high potential for abuse and severe psychological or physical dependence.
  • Schedule III (C3) substances have a lower potential for abuse and are considered to have a currently accepted medical use in treatment in the United States.
  • Schedule IV (C4) involves drugs with even lower abuse potential.

When codeine is used in combination with non-narcotic medications like acetaminophen, the classification can change. Specifically, if the formulation contains a lower dosage of codeine (generally not exceeding 90 mg per dosage unit with other non-narcotic analgesics), it could fall under Schedule III.

In this scenario, 300 mg of codeine is combined with 3250 mg of acetaminophen to make 10 capsules. Each capsule contains less than 90 mg

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