Levonorgestrel Tablet 1.5 Mg

Levonorgestrel Tablet 1.5 Mg
SPL v3
SPL
SPL Set ID be8b7ace-9af8-4417-85fa-863e19072887
Route
ORAL
Published
Effective Date 2025-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levonorgestrel (1.5 mg)
Inactive Ingredients
Silicon Dioxide Starch, Potato Magnesium Stearate Talc Starch, Corn Lactose Monohydrate

Identifiers & Packaging

Pill Appearance
Imprint: EE1 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2023-02-16

Description

Drug Facts

Purpose

Emergency contraceptive


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.

Section 50567-7

When using this product you may have

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

If you have questions or need more information, call our toll-free number, x-xxx-xxx-xxxx.

Allergy Alert

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

Active Ingredient

Levonorgestrel 1.5 mg

Other Information
  • read the instructions, warnings and enclosed product leaflet before use
  • do not use if carton is open or tear strip is removed or blister seal is broken or missing
  • store at 20-25°C (68-77°F)
Inactive Ingredients

colloidal anhydrous silica, corn starch, lactose monohydrate, magnesium stearate, potato starch and purified talc

Principal Display Panel 

FOR CLINIC USE ONLY.

NOT FOR RETAIL SALE.

NDC 79929-016-01

levonorgestrel 1.5 mg

emergency contraceptive

Reduces chance of

pregnancy after

unprotected sex.

Not for regular birth control.

One Tablet.

One Step.

1 Tablet Levonorgestrel 1.5 mg

Sexually Transmitted Diseases (stds) Alert

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


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.

Section 50567-7 (50567-7)

When using this product you may have

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

If you have questions or need more information, call our toll-free number, x-xxx-xxx-xxxx.

Allergy Alert (Allergy alert)

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

Active Ingredient (Active ingredient)

Levonorgestrel 1.5 mg

Other Information (Other information)
  • read the instructions, warnings and enclosed product leaflet before use
  • do not use if carton is open or tear strip is removed or blister seal is broken or missing
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

colloidal anhydrous silica, corn starch, lactose monohydrate, magnesium stearate, potato starch and purified talc

Principal Display Panel  (PRINCIPAL DISPLAY PANEL )

FOR CLINIC USE ONLY.

NOT FOR RETAIL SALE.

NDC 79929-016-01

levonorgestrel 1.5 mg

emergency contraceptive

Reduces chance of

pregnancy after

unprotected sex.

Not for regular birth control.

One Tablet.

One Step.

1 Tablet Levonorgestrel 1.5 mg

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)