FDA Label for Levonorgestrel
View Indications, Usage & Precautions
Levonorgestrel Product Label
The following document was submitted to the FDA by the labeler of this product Oc Pharma, Llc. 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
Active Ingredient
Levonorgestrel 1.5mg
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 - When Using
When using this product you may have
- menstrual changes
- tiredness
- breast pain
- nausea
- headache
- vomiting
- lower stomach (abdominal) pain
- dizziness
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.
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 of taking the medication, call a healthcare professional to find out if you should repeat that 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 the carton is open or blister seal is broken or missing
- store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
colloidal silicon dioxide, FD&C Yellow No.6 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch
Questions Or Comments?
Call 1-800-224-4606.
Principal Display Panel - 1.5 Mg Tablet Blister Pack Carton
NDC 49615-017-01
Levonorgestrel Tablet
1.5 mg
Emergency Contraceptive
Reduces chance of pregnancy after unprotected sex.
Not for regular birth control.
ONE TABLET. ONE DOSE.
OC
Pharma
Contains 1 Levonorgestrel Tablet 1.5 mg
- 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.
* Please review the disclaimer below.