Key Marketed Proprietary Products > PLAN B®

PLAN B®, which contains the synthetic progestin levonorgestrel, is an emergency contraceptive intended to prevent pregnancy when taken as directed as soon as possible within 72 hours following unprotected intercourse or contraceptive failure. In August 2006, the FDA approved the application to market PLAN B® as an over-the-counter (OTC) product for consumers 18 years of age and older, while maintaining the prescription status for women 17 and younger.

Duramed implemented and supports a CARE^SM program (Convenient Access, Responsible Education) that provides information to pharmacists, physicians and other healthcare providers, as well as consumers, regarding the appropriate distribution and use of PLAN B® due to its dual-label status. The CARESM program also monitors compliance with prescription age requirements of PLAN B® OTC/Rx and includes a comprehensive education program for healthcare professionals and consumers. In addition, Duramed Research supports various continuing education programs for pharmacists and other healthcare practitioners and has in place a comprehensive publication plan. Duramed continues to work closely with retail pharmacies and drug wholesalers to ensure that they understand and follow the FDA's prescription age requirement for the dispensing of the product. Duramed also engages in journal advertising and supports consumers through a robust DTC (Direct to Consumer) advertising effort.

Important Safety Information

PLAN B® is indicated to prevent pregnancy following unprotected intercourse or contraceptive failure. PLAN B® is contraindicated in women with known or suspected pregnancy or hypersensitivity to any component of the product. PLAN B® is not recommended for routine use as a contraceptive, because it isn't as effective. PLAN B® is not effective in terminating an existing pregnancy. PLAN B® does not protect against HIV infection and other sexually transmitted infections (STIs). Menstrual bleeding may be heavier or lighter, earlier or later after taking PLAN B®. If menses is delayed beyond one week, the patient may be pregnant. Severe abdominal pain may signal a tubal (ectopic) pregnancy. Common side effects associated with the use of PLAN B® include nausea, abdominal pain, fatigue, headache, menstrual changes, dizziness, breast tenderness, vomiting and diarrhea.

For complete product information, please visit www.Go2PlanB.com.

Click HERE to download full U.S. Prescribing Information.

Click HERE to be taken to the product guide website.