FDA Label for Empowered Choice
View Indications, Usage & Precautions
Empowered Choice Product Label
The following document was submitted to the FDA by the labeler of this product Versea Diagnostics. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Levonorgestrel, USP 1.5 mg
Purpose
Emergency Contraceptive
Use
for women to reduce chance of pregnancy af ter unprotected sex (if a contraceptive failed or if you did not use bir th control)
Warnings
Allergy alert
Do not use if you have ever had an allergic reaction to levonorgestrel.
Sexually transmitted diseases (STDs) alert
This product does not protect against HIV/AIDS or other STDs.
Do not use
• if you are already pregnant (because it will not work)
• for regular birth control
Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.
When using this product you may have
• menstrual changes
• tiredness
• breast pain
• nausea
• headache
• vomiting
• lower stomach (abdominal) pain
• dizziness
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
• take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it, the better it will work.
• if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose
Other Information
• read the instructions, warnings, and enclosed product leaflet before use
• this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation).
• do not use if carton is open or tear strip is removed or blister seal is broken or missing
• store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc
Questions?
Call 1-800-397-0670
Other
Distributed by:
Versea Diagnostics, LLC
Tampa, FL 33602
Principal Display Panel
NDC 83567-7003-5
*Compare to the active ingredient of Plan B One-Step ®
EMPOWERED CHOICE TM
Levonorgestrel Tablet 1.5 mg
Emergency Contraceptive
1 Tablet Levonorgestrel 1.5 mg
One Tablet. One Step.
- Reduces the chance of pregnancy after unprotected sex
- Not for regular birth control
- The sooner you take it, the more effective it will be
- Take as soon as possible within 72 hours (3 days) after unprotected sex
- Will not harm an existing pregnancy
* Please review the disclaimer below.
