Which item is the fixed combination product with Difenoxin and Atropine Sulfate in a dosage unit?

• A. Promethazine + Codeine
• B. 100 mg Opium / 100 mL or 100 grams
• C. not more than 0.5 mg Difenoxin and not less than 25 mcg Atropine Sulfate / dosage unit
• D. APAP + Codeine Elixir

Answer: (C)

The item being tested is the regulatory limit for a fixed-dose product containing difenoxin with atropine sulfate. These combinations are tightly controlled to deter abuse: per dosage unit, you can have not more than 0.5 mg of difenoxin and not less than 25 mcg of atropine sulfate. The atropine is included in a subtherapeutic amount to discourage misuse, while difenoxin provides the therapeutic effect for diarrhea. The other options describe different drug combos or general quantity limits that don’t specify this difenoxin–atropine fixed-dose standard. This option exactly matches the per-dosage-unit limits that define the fixed-dose product.