Label: LEVONORGESTREL tablet
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated October 26, 2017
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient
Sexually transmitted diseases (STDs) alert
This product does not protect against HIV/AIDS or other STDs
When using this product you may have
- menstrual changes
- breast pain
- lower stomach (abdominal) pain
- 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 the carton is open or blister seal is broken or missing
- store at 20° to 25°C (68° to 77°F)
- Inactive ingredients
- Questions or comments?
PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton
Reduces chance of pregnancy after unprotected sex.
Not for regular birth control.
ONE TABLET. ONE DOSE.
Contains 1 Levonorgestrel Tablet 1.5 mg
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.
- The sooner you take it, the more
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49615-017 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 Silicon Dioxide (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Lactose Monohydrate (UNII: EWQ57Q8I5X) Magnesium Stearate (UNII: 70097M6I30) Starch, corn (UNII: O8232NY3SJ) Product Characteristics Color ORANGE Score no score Shape ROUND Size 8mm Flavor Imprint Code 17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49615-017-01 1 in 1 CARTON 12/31/2018 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 ANDA202380 12/01/2018 Labeler - OC Pharma, LLC (171268936)