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
Drug Label Information
Updated June 20, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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Warnings
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.
- Directions
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Other information
- •
- read the instructions, warnings, and enclosed product leaflet before use
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- 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).
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- do not use if carton is open or tear strip is removed or blister seal is broken or missing
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- store at 20° to 25°C (68° to 77°F)
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton
LEADER™
NDC 70000-0600-1
Levonorgestrel
Tablet, 1.5 mg
Emergency ContraceptiveReduces the Chance of Pregnancy
after Unprotected SexNot for Regular Birth Control
The Sooner You Take It, the More
Effective It Will BeTake as Soon as Possible within 72
Hours (3 Days) after Unprotected SexWill Not Harm an Existing Pregnancy
One Tablet, One Step
COMPARE TO
PLAN B ONE-STEP®
active ingredient†100% Money
Back Guarantee1 LEVONORGESTREL TABLET
SEE NEW WARNING
-
INGREDIENTS AND APPEARANCE
LEADER EMERGENCY CONTRACEPTIVE LEVONORGESTREL
levonorgestrel tabletProduct 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)