FDA Label for Leader Emergency Contraceptive Levonorgestrel
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT
- PURPOSE
- USE
- ALLERGY ALERT
- SEXUALLY TRANSMITTED DISEASES (STDS) ALERT
- DO NOT USE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 1.5 MG TABLET BLISTER PACK CARTON
Leader Emergency Contraceptive Levonorgestrel Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
Active Ingredient
Levonorgestrel, USP 1.5 mg
Purpose
Emergency contraceptive
Use
for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
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.
Do Not Use
• if you are already pregnant (because it will not work)• for regular birth control
Otc - Ask Doctor/Pharmacist
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.
Otc - When Using
When using this product you may have
• menstrual changes• tiredness• dizziness• nausea• headache• breast pain• lower stomach (abdominal) pain• vomiting
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
• take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it, the better it will work.• if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose
Other Information
• 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
colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc
Questions Or Comments?
For more information, call toll free 1-800-406-7984 weekdays
Principal Display Panel - 1.5 Mg Tablet Blister Pack Carton
LEADER™
NDC 70000-0600-1
Levonorgestrel
Tablet, 1.5 mg
Emergency Contraceptive
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
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PLAN B ONE-STEP®
active ingredient†
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1 LEVONORGESTREL TABLET
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