Morning After Pill Tablet
FDA Label NDC 73436-8292

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 73436-8292). 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 drug facts, active ingredient (in each tablet), purpose, use, warnings, do not use, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

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

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
  • nausea
  • lower stomach (abdominal) pain
  • tiredness
  • headaches
  • dizziness
  • breast pain
  • vomiting

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control center at (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 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
  • 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

lactose monohydrate, corn starch potato starch, colloidal silicon dioxide, talc, magnesium stearate

Questions Or Comments?

Call 1-877-862-7455, Monday - Friday 8am - 5pm CST, or visit us at cadenceotc.com

Other

NDC 73436-8292-1

Manufactured for:
Cadence OTC

Oakland CA 94612

Product made in India

UK/Drugs/12/UA/SC/P-2009

Package Label.Principal Display Panel

1. NDC 73436-8292-1

Morning After Pill

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

    Morning After Pill (Cadence India Carton)

    Morning After Pill (Cadence India Carton)

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