Which of the following statements about package insert in NOT TRUE?
A. It provides very detailed information about the drug.
B. The information on package insert is provided by the drug manufacturer.
C. The information on package insert is approved by a regulatory agency such as FDA.
D. It includes all the possible uses of the drug.
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Generic name is the name for _________.
A. active ingredient
B. the whole drug product
C. excipient
D. chemical structure
Which of the following is not included in the section of “Description” of a package insert?
A. drug appearance, taste and odor
B. physical properties
C. pharmacologic class
D. side effect
Which of the following is not included in the section of “Dosage and Administration” of a package insert?
A. dose
B. incidence of adverse reaction
C. dosing frequency
D. route of administration
Strength of a drug product refers to _______.
A. the weight of the whole unit dosage form
B. the amount of active ingredient that is contained in each unit dosage form
C. the hardness of the dosage form
D. the size of the tablet