Are package inserts required in all labeling pieces for products that are the same except for different strengths or dosages?
Yes. Even though products may be very similar, package inserts may be different for different dosage forms or different delivery systems for the same drug. The regulations would require a package insert for each dosage form and delivery system for which claims appear in the promotional labeling piece. Some drug products, however, have multi-dosage form package inserts. In those cases, the same package insert could be attached to each piece, even if the dosage forms or delivery systems were different.
