SPL v2
SPL
SPL Set ID 2fb59f53-d885-9d4a-e063-6394a90a88cc
Route
ORAL
Published
Effective Date 2025-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: EE1 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2025-04-15

Description

Levonorgestrel 1.5 mg

Purpose

Emergency contraceptive


Medication Information

Purpose

Emergency contraceptive

Description

Levonorgestrel 1.5 mg

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

NDC 73436-8292-1

Manufactured for:

Cadence OTC

Oakland CA 94612

Product made in India

UK/Drugs/12/UA/SC/P-2009

Section 50567-7

When using this product you may have

  • menstrual changes
  • nausea
  • lower stomach (abdominal) pain
  • tiredness
  • headaches
  • dizziness
  • breast 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.

Section 51945-4

1. NDC 73436-8292-1

Morning After Pill

Levonorgestrel 1.5 mg

Emergency contraceptive

Reduces chance of pregnancy after unprotected sex

Not for regular birth control

Won't interefere with your ability to get pregnant later

  • 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

1 TABLET LEVONORGESTREL 1.5MG

Warnings

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

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
Drug Facts

Other Information
  • read the instructions, warnings, and enclosed product leaflet before use
  • 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

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

Questions Or Comments?

Call 1-877-862-7455, Monday - Friday 8am - 5pm CST, or visit us at cadenceotc.com

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control center at (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Levonorgestrel 1.5 mg


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)

NDC 73436-8292-1

Manufactured for:

Cadence OTC

Oakland CA 94612

Product made in India

UK/Drugs/12/UA/SC/P-2009

Section 50567-7 (50567-7)

When using this product you may have

  • menstrual changes
  • nausea
  • lower stomach (abdominal) pain
  • tiredness
  • headaches
  • dizziness
  • breast 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.

Section 51945-4 (51945-4)

1. NDC 73436-8292-1

Morning After Pill

Levonorgestrel 1.5 mg

Emergency contraceptive

Reduces chance of pregnancy after unprotected sex

Not for regular birth control

Won't interefere with your ability to get pregnant later

  • 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

1 TABLET LEVONORGESTREL 1.5MG

Purpose

Emergency contraceptive

Warnings

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

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
Drug Facts

Other Information (Other information)
  • read the instructions, warnings, and enclosed product leaflet before use
  • 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)

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

Questions Or Comments? (Questions or comments?)

Call 1-877-862-7455, Monday - Friday 8am - 5pm CST, or visit us at cadenceotc.com

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 at (1-800-222-1222) right away.

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Levonorgestrel 1.5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)