Label: LEADER EMERGENCY CONTRACEPTIVE LEVONORGESTREL- levonorgestrel tablet
- NDC Code(s): 70000-0600-1
- Packager: Cardinal Health 110, LLC. DBA Leader
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated June 20, 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 tear strip is removed 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
Tablet, 1.5 mg
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
One Tablet, One Step
PLAN B ONE-STEP®
1 LEVONORGESTREL TABLET
SEE NEW WARNING
INGREDIENTS AND APPEARANCE
LEADER EMERGENCY CONTRACEPTIVE LEVONORGESTREL
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0600 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) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) 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:70000-0600-1 1 in 1 CARTON 03/22/2022 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 ANDA202635 03/22/2022 Labeler - Cardinal Health 110, LLC. DBA Leader (063997360) Establishment Name Address ID/FEI Business Operations Sun Pharmaceutical Industries Limited 725959238 MANUFACTURE(70000-0600)