Levonorgestrel
FDA Label NDC 49615-017

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oc Pharma, Llc for the product Levonorgestrel (NDC 49615-017). 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 other, active ingredient, purpose, use, allergy alert, sexually transmitted diseases (stds) alert, do not use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.
    • Principal Display Panel (1.5 mg Tablet Blister Pack Carton)

    Principal Display Panel (1.5 mg Tablet Blister Pack Carton)

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