"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"...
DOSAGE AND ADMINISTRATION
Instruct patients to take one tablet orally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure.
The tablet can be taken with or without food.
If vomiting occurs within 3 hours of ella intake, consideration should be given to repeating the dose.
ella can be taken at any time during the menstrual cycle.
Dosage Forms And Strengths
The ella tablet is supplied as a white to off-white, round, curved tablet containing 30 mg of ulipristal acetate and is marked “ella” on both sides.
Storage And Handling
ella (ulipristal acetate) tablet, 30 mg is supplied in a PVC-PE-PVDC-aluminum blister. The tablet is a white to off-white, round, curved tablet marked with “ella” on both sides.
NDC 50102-911-01 (1 tablet unit of use package)
Store at 20-25°C (68-77°F). [See USP controlled room temperature.]
Keep the blister in the outer carton in order to protect from light. Keep out of reach of children.
For all medical inquiries contact: Afaxys, Inc. Health and Safety Team Charleston, SC, 29403, USA. 1-855-888-2467. Distributed By: Afaxys, Inc. Charleston, SC, 29403, USA. Revised: March 2015
Last reviewed on RxList: 3/30/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Ella Information
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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