Active Ingredient
Levonorgestrel 1.5 mg
Morning After Pill Tablet
FDA Label NDC 73436-2859
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cadence Health Inc for the product Morning After Pill (NDC 73436-2859). 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, purpose, use, allergy alert, sexually transmitted diseases (stds) alert, do not use, otc - ask doctor, otc - when using, 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)
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
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
- nausea
- lower stomach (abdominal) pain
- tiredness
- headache
- dizziness
- breast 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 of 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
- do not use if 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 1-877-862-7455
Monday - Friday 8 AM - 5 PM CST or visit us at cadenceotc.com
Other
Manufactured for:
Cadence OTC
Oakland CA, 94612
NDC 73436-2859-1
Product made in Germany
Issued: September 2023
Package Label.Principal Display Panel
1. NDC 73436-2859-1
Morning After Pill TM
Levonorgestrel 1.5 mg
Emergency contraceptive
Reduces chance of pregnancy after unprotected sex
Not for regular birth control
Won't interefere with your ability to get pregnant later
- 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
1 TABLET LEVONORGESTREL 1.5MG
Image Description (Cadence)
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