FDA Label for Emergency Contraceptive
View Indications, Usage & Precautions
Emergency Contraceptive Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health (leader) 70000. 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.
Active Ingredient ( In Each Tablet)
Levonorgestrel 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)
Warnings
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
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.
When Using The Product You May Have
- menstrual changes
- nausea
- lower stomach(abdominal) pain
- tiredness
- headache
- dizziness
- breast pain
- vomiting
Keep Out Of Reach Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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 attachmentof a fertilized egg to the uterus (implantation).
- do not use if package is open or blister seal is broken or missing
- store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Inactive Ingredients
croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 188
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COMPARE TO PLAN B ONE-STEP® active ingredient*
Levonorgestrel Tablet 1.5 mg
Emergency Contraceptive
Reduces chances 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
Tablet
*This product is not manufactured or distributed by Foundation Consumer Healthcare LLC, distributor of Plan B One Step®.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
Package Label
LEADER Emergency Contraceptive 1.5 mg
* Please review the disclaimer below.