collection of information

about a given drug that’s required by the Food and Drug

Administration (FDA) to describe the characteristics of the

drug. The order of the information must be the same as required by the FDA.

copy of a drug monograph that accompanies the drug in its package when distributed for sale and

use.

Name

boxed warning

description

clinical pharmacology

indications and usage

contraindictions

warnings

precautions

adverse reactions

overdosage

dosage and administration

how supplied

highlights of prescribing information:

limitations statement

product name

initial date of US approval

boxed warning

recent major changes:

indications and usage

dosage and administration

dosage forms and strength

contraindictions

warnings and precautions

adverse reactions

adverse reactions reporting contact information

drug interaction

use specific populations

patient counseling information statement

Boxed Warning

• Indications and Usage

• Dosage and Administration

• Dosage Forms and Strengths

• Contraindications

• Warnings and Precautions

• Adverse Reactions

• Drug Interactions

• Use in Specific Populations 

Drug Abuse and Dependence

• Overdosage

• Description

• Clinical Pharmacology

• Nonclinical Toxicology 

Clinical Studies

References

How supplied storage and handling

patient counseling information