Label: LEVONORGESTREL tablet
- NDC Code(s): 73358-911-01
- Packager: Curae Pharma360 Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated October 17, 2022
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
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
- 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 blister seal is broken or missing
- store at 20° to 25°C (68° to 77°F)
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton
Reduce 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
Contains 1 levonorgestrel tablet
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73358-911 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 Lactose Monohydrate (UNII: EWQ57Q8I5X) Starch, Corn (UNII: O8232NY3SJ) Magnesium Stearate (UNII: 70097M6I30) Silicon Dioxide (UNII: ETJ7Z6XBU4) Fd&C Yellow No. 6 (UNII: H77VEI93A8) Product Characteristics Color ORANGE (Light peach) Score no score Shape ROUND (Round convex) Size 8mm Flavor Imprint Code 17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73358-911-01 1 in 1 CARTON 10/17/2022 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 10/17/2022 Labeler - Curae Pharma360 Inc. (080719852) Registrant - Naari Pte. Limited (659345996)