package insert

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package insert

printed materials available in the legal pharmacologic description of a drug, subject to detailed regulatory specifications, including approved chemical and proprietary names, description and classification, clinical pharmacology, approved indications and usage, contraindications, warnings, precautions, adverse reactions, drug abuse and dependence information, overdosage discussion, dosage and administration, formulations, and appropriate references; in the U.S., such materials are negotiated between the drug's manufacturer(s) and the U.S. Food and Drug Administration.
See also: label (3).

package insert (P.I.)

a leaflet that, by order of the U.S. Food and Drug Administration, must be placed inside the package of every prescription drug. The leaflet must include the trademark for the drug, its generic name, and its mechanism of action; state its indications, contraindications, warnings, precautions, adverse effects, and dosage forms; and include instructions for the recommended dose, time, and route of administration.


A description of a drug product or device provided by the manufacturer and approved by the regulatory authority of a particular country or jurisdiction, which includes indications for its use, who should use it, adverse events, instructions for use, and safety information.

package insert

Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific information–eg, indications for use; forms of administration, side effects, etc; it is more cynically described as a hard-to-handle and difficult-to-read package 'stuffer' printed in Lilliputian type on Bible paper. See Advertising.

pack·age in·sert

(pak'ăj in'sĕrt)
A manufacturer's printed guideline for the use and dosing of a drug; includes the pharmacokinetics, dosage forms, and other relevant information about a drug.
References in periodicals archive ?
The Kotzes complained to the company about the lack of 'appropriate' warnings on the Mefliam package insert, contending that insomnia and other side-effects should have been included.
In the context of health care liability claims, the key question is the role, if any, of the package insert in the evaluation of physician conduct.
Kniffin acknowledged, however, that since Duragesic's market introduction, Janssen and Alza have changed the package inserts to emphasize the importance of proper dosages and to display more prominent warnings about potential risks of using the drug.
For more information about BioThrax, please review the package insert located on the Company's website www.
The FDA re-labeled yesterday the warfarin package insert recommending the testing of multiple genetic variants in two genes namely 2C9 and VKORC1 for safer drug dosing.
For additional information on the product, please access the package insert at http://www.
Critically evaluate the needs of the package insert and marketing application up front, before getting deeply into clinical trials.
In addition, the FDA has stated its intent to issue a combined package insert in lieu of individual package inserts for each IR (capsule) and MR (tablet) NDA.
The Food and Drug Administration (FDA) and HL7 have been working together to develop a standard for communicating product label information that can be used in clinical information systems and allow easier access to package insert information for consumers.
We believe these changes to our package insert will further enhance our efforts to minimize abuse and diversion of OxyContin(R) Tablets, while continuing to ensure that legitimate patients continue to have access to this medication," stated Michael Friedman, Chief Operating Officer of Purdue Pharma.
As reported in the FDA-approved package insert, MultiHance, unlike other available gadolinium contrast agents, demonstrates weak and transient interactions with serum proteins, which result in a proton magnetic relaxivity that is approximately twice that of Magnevist.
That's why the overwhelming response to the Glamour/Hanes Hand in Hand package insert last year was particularly gratifying.