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The following information must be on every prescription label: Name and address of the dispensing pharmacy. Serial number of the prescription. Date of the prescription. Name of the prescriber. Name of the patient. Name and strength of the drug.

The Selected Requirement of Prescribing Information (SRPI) is a 41-item, drop-down checklist of important format elements of the Prescribing Information (PI) based on labeling regulations (21 CFR 201.56 and 201.57) and guidances. There is one drop-down menu and one comment field for each item.

The following list is an outline of the requirements in a drug label: Highlights (a concise summary of label information) Full prescribing Information. Limitations Statement. Product Names. Date of Initial U.S. Approval. Boxed Warning. Recent Major Changes. Indications and Usage.

Highlights of Prescribing Information. ... Section 1: Indications and Usage. ... Section 2: Dosage and Administration. ... Section 3: Dosage Forms and Strengths. ... Section 4: Contraindications. ... Section 5: Warnings and Precautions. ... Section 6: Adverse Reactions. ... Section 7: Drug Interactions.

Includes the established pharmacological class, chemical name, structural formula, dosage form, route of administration, active and inactive ingredients, and other important physical or chemical information to assure safe use.

Each sample unit shall bear a label that clearly denotes its status as a drug sample, e.g., "sample," "not for sale," "professional courtesy package." (1) A drug that is labeled as a drug sample is deemed to be a drug sample within the meaning of the act.

The label shall contain information about the name and address of the manufacturer, packer, or distributor. Besides, it shall contain adequate direction for use, including conditions and purposes, drug dosage, timing and route of administration.