Levonorgestrel Tablets

Levonorgestrel Tablets
SPL v1
SPL
SPL Set ID c7698816-6ac6-48c6-aaff-c484ebbafed3
Route
ORAL
Published
Effective Date 2017-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levonorgestrel (1.5 mg)
Inactive Ingredients
Silicon Dioxide Fd&c Yellow No. 6 Lactose Monohydrate Magnesium Stearate Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: 17 Shape: round Color: orange Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2018-12-01

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
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.
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 1.5mg

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.

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

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.

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
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 of taking the medication, call a healthcare professional to find out if you should repeat that 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 1.5mg

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 the carton is open or blister seal is broken or missing
  • store at 20° to 25°C (68° to 77°F)
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, FD&C Yellow No.6 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch

Questions Or Comments? (Questions or comments?)

Call 1-800-224-4606.

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)

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.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)