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Plan B One-Step

"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...

Plan B One-Step

Plan B One-Step

INDICATIONS

Plan B® One-Step is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the tablet should be taken as soon as possible within 72 hours of intercourse.

Plan B One-Step is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older.

Plan B One-Step is not indicated for routine use as a contraceptive.

DOSAGE AND ADMINISTRATION

Take Plan B One-Step orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse. Plan B One-Step can be used at any time during the menstrual cycle.

If vomiting occurs within two hours of taking the tablet, consideration should be given to repeating the dose.

HOW SUPPLIED

Dosage Forms And Strengths

The Plan B One-Step tablet is supplied as an almost white, round tablet containing 1.5 mg of levonorgestrel and is marked G00 on one side.

Storage And Handling

The Plan B One-Step (levonorgestrel) tablet 1.5 mg is available in a PVC/aluminum foil blister package. The tablet is almost white, round, and marked G00 on one side.

NDC 51285-088-88 (1 tablet unit of use package)

Store Plan B One-Step at 20°to 25°C (68°to 77°F) [see USP Controlled Room Temperature].

Mfg. by Gedeon Richter, Ltd., Budapest, Hungary for Duramed Pharmaceuticals, Inc., Subsidiary of Barr Pharmaceuticals, Inc., Pomona, New York 10970. Phone: 1-800-330-1271. Website: www.PlanBOneStep.com. Revised: July 2009.

Last reviewed on RxList: 7/30/2009
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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