OTC Medication Labeling
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Questions and Answers

What is a key consideration for cGMP compliance in OTC labeling?

  • Listing inactive ingredients to inform consumers of the complete formulation
  • Ensuring each package is labeled with a batch number and an expiration date (correct)
  • Incorporating features to indicate if the packaging has been tampered with
  • Including clear instructions on how to use the product
  • What information should be clearly listed for OTC medications to comply with cGMP?

  • Purpose of the product
  • Standardized for
  • Batch numbers and expiry dates (correct)
  • Inactive ingredients only
  • Why is it important to clearly state the intended use or purpose of the OTC medication?

  • To provide accurate information on active ingredients and dosages
  • To ensure safety and efficacy of the product (correct)
  • To maintain product integrity
  • To inform consumers of the complete formulation
  • What is the purpose of incorporating tamper-evident features in OTC medication packaging?

    <p>To indicate if the packaging has been tampered with</p> Signup and view all the answers

    What does compliance with cGMP in OTC labeling require regarding active ingredients and dosages?

    <p>Clearly listing active ingredients and their respective dosages</p> Signup and view all the answers

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