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e-CFR data is current as of September 22, 2020

Title 21Chapter ISubchapter CPart 201Subpart B → §201.55


Title 21: Food and Drugs
PART 201—LABELING
Subpart B—Labeling Requirements for Prescription Drugs and/or Insulin


§201.55   Statement of dosage.

Section 201.100(b)(2) requires that labels for prescription drugs bear a statement of the recommended or usual dosage. Since the dosage for some prescription drugs varies within extremely wide limits, depending upon the conditions being treated, it may not be possible in all cases to present an informative or useful statement of the recommended or usual dosage in the space available on the label or carton of the package. It is the view of the Food and Drug Administration that when such a situation prevails, compliance with this requirement would be met by a statement such as “See package insert for dosage information”, where the detailed information is contained in such insert. However, if an informative, realistic, recommended or usual dosage can readily be set forth on the label, it should appear thereon.

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