Leader

Drug Facts

Composition & Product

Active Ingredients

Levonorgestrel (1.5 mg)

Inactive Ingredients

Silicon Dioxide Starch, Corn Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Talc

Identifiers & Packaging

Pill Appearance

Imprint: 718 Shape: round Color: white Size: 8 mm Score: 1

Marketing Status

ANDA Active Since 2022-03-22

Medication Information

Purpose

Emergency contraceptive

Description

Drug Facts

Use

for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50567-7

When using this product you may have

•
menstrual changes
•
tiredness
•
dizziness
•
nausea
•
headache
•
breast pain
•
lower stomach (abdominal) pain
•
vomiting

Section 50568-5

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.

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

Do Not Use

•
if you are already pregnant (because it will not work)
•
for regular birth control

Allergy Alert

Do not use if you have ever had an allergic reaction to levonorgestrel

Active Ingredient

Levonorgestrel, USP 1.5 mg

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

Sexually Transmitted Diseases (stds) Alert

This product does not protect against HIV/AIDS or other STDs.

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

COMPARE TO

PLAN B ONE-STEP^®

active ingredient^†

100% Money

Back Guarantee

1 LEVONORGESTREL TABLET

SEE NEW WARNING

Structured Label Content

Use

for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50567-7 (50567-7)

When using this product you may have

•
menstrual changes
•
tiredness
•
dizziness
•
nausea
•
headache
•
breast pain
•
lower stomach (abdominal) pain
•
vomiting

Section 50568-5 (50568-5)

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.

Purpose

Emergency contraceptive

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

Do Not Use (Do not use)

•
if you are already pregnant (because it will not work)
•
for regular birth control

Allergy Alert (Allergy alert)

Do not use if you have ever had an allergic reaction to levonorgestrel

Active Ingredient (Active ingredient)

Levonorgestrel, USP 1.5 mg

Other Information (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 (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Sexually Transmitted Diseases (stds) Alert (Sexually transmitted diseases (STDs) alert)

This product does not protect against HIV/AIDS or other STDs.

Principal Display Panel 1.5 Mg Tablet Blister Pack Carton (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

COMPARE TO

PLAN B ONE-STEP^®

active ingredient^†

100% Money

Back Guarantee

1 LEVONORGESTREL TABLET

SEE NEW WARNING

Advanced Ingredient Data

[{"name": "LEVONORGESTREL", "unii": "5W7SIA7YZW", "classCode": "ACTIB", "strengthNumerator": "1.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)", "42229-5": "Drug Facts", "50565-1": "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).", "50567-7": "When using this product you may have • menstrual changes • tiredness • dizziness • nausea • headache • breast pain • lower stomach (abdominal) pain • vomiting", "50568-5": "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.", "Purpose": "Emergency contraceptive", "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", "Do not use": "• if you are already pregnant (because it will not work) • for regular birth control", "Allergy alert": "Do not use if you have ever had an allergic reaction to levonorgestrel", "Active ingredient": "Levonorgestrel, USP 1.5 mg", "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", "Sexually transmitted diseases (STDs) alert": "This product does not protect against HIV/AIDS or other STDs.", "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 COMPARE TO PLAN B ONE-STEP ® active ingredient † 100% Money Back Guarantee 1 LEVONORGESTREL TABLET SEE NEW WARNING"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information