Active Ingredient (In Each Tablet)
Levonorgestrel 1.5 mg
Emergency Contraceptive Tablet
FDA Label NDC 59726-138
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by P & L Development, Llc for the product Emergency Contraceptive (NDC 59726-138). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, use, warnings, do not use, ask a doctor or pharmacist before use if you are, when using this product you may have, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 medications may reduce the effectiveness of levonorgestrel.
When Using This Product You May Have
- menstrual changes
- tiredness
- breast pain
- nausea
- headache
- vomiting
- lower stomach (abdominal) pain
- dizziness
Keep Out Of Reach Of 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 release egg (joining of sperm and egg) or attachment of 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, lactrose 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 the active ingredient in Plan B One-Step®†
emergency contraceptive
levonorgestrel
Tablet 1.5 mg
one tablet. one step.
- 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
reduces chance of pregnancy after unprotected sex not for regular birth control
tablet 1.5 mg
†This product is not manufactured or distributed by Foundation Consumer Healthcare LLC, distributor of Plan B One Step®.
Distributed by:
PL Developments
200 Hicks Street
Westbury, NY 11590
Package Label
READYinCASE Emergency Contraceptive
* Please review the disclaimer below.
