Label: EMERGENCY CONTRACEPTIVE- levonorgestrel tablet
- NDC Code(s): 0536-1391-63
- Packager: Rugby Laboratories, Inc.
- This is a repackaged label.
- Source NDC Code(s): 70700-164
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated June 2, 2023
If you are a consumer or patient please visit this version.
- Active ingredient ( in each tablet)
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
Ask a doctor or pharmacist before use if you are
taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medication may reduce the effectiveness of levonorgestrel.
- Keep out of reach 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 attachmentof a fertilized egg to the uterus (implantation).
- do not use if package is open or blister seal is broken or missing
- store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].
- Inactive ingredients
- Questions or comments?
Principal display panel
Compare to the active ingredient in Plan B One-Step**
Levonorgestrel Tablet 1.5 mg
Reduces chances of pregnancy after unprotected sex
Not for regular birth control
One Tablet. One Step
- 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
*This product is not manufactured or distributed by Foundation Consumer Healthcare LLC, distributor of Plan B One Step®.
Indianapolis, IN 46268
- Package label
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1391(NDC:70700-164) 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLOXAMER 188 (UNII: LQA7B6G8JG) Product Characteristics Color white (White to off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code C;1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1391-63 1 in 1 CARTON 08/01/2023 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 ANDA205329 08/01/2023 Labeler - Rugby Laboratories, Inc. (079246066)