Leader Emergency Contraceptive Levonorgestrel Tablet
FDA Label NDC 70000-0600

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Leader Emergency Contraceptive Levonorgestrel (NDC 70000-0600). 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 - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

Active Ingredient

Levonorgestrel, USP 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)

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
  • tiredness
  • dizziness
  • nausea
  • headache
  • breast pain
  • lower stomach (abdominal) 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 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 released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation).
  • do not use if carton is open or tear strip is removed or blister seal is broken or missing
  • store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

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

Questions Or Comments?

For more information, call toll free 1-800-406-7984 weekdays

Principal Display Panel - 1.5 Mg Tablet Blister Pack Carton

LEADER™

NDC 70000-0600-1

Levonorgestrel

Tablet, 1.5 mg
Emergency Contraceptive

Reduces the Chance of Pregnancy
after Unprotected Sex

Not for Regular Birth Control

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

One Tablet, One Step

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PLAN B ONE-STEP®
active ingredient†

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1 LEVONORGESTREL TABLET

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Principal Display Panel (1.5 mg Tablet Blister Pack Carton)

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