Label: EMPOWERED CHOICE- levonorgestrel 1.5 mg tablet
- NDC Code(s): 83567-7003-5
- Packager: Versea Diagnostics
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated July 26, 2023
If you are a consumer or patient please visit this version.
- Drug Facts
- ACTIVE INGREDIENT
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
• breast pain
• lower stomach (abdominal) pain
- KEEP OUT OF REACH OF CHILDREN
• 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
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
*Compare to the active ingredient of Plan B One-Step ®
EMPOWERED CHOICE TM
Levonorgestrel Tablet 1.5 mg
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
INGREDIENTS AND APPEARANCE
levonorgestrel 1.5 mg tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83567-7003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL 1.5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color white (white to off-white) Score no score Shape ROUND (circular) Size 8mm Flavor Imprint Code 718 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83567-7003-5 1 in 1 CARTON 09/01/2023 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202635 08/25/2023 Labeler - Versea Diagnostics (118736277)