SPL v4
SPL
SPL Set ID fc5d29bb-4a4b-e61e-e053-6394a90a8a62
Route
ORAL
Published
Effective Date 2025-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 17 Shape: round Color: orange Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2023-10-01

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

Manufactured for:

Cadence OTC

Oakland CA, 94612

NDC 73436-2859-1



Product made in Germany

Issued: September 2023

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
  • nausea
  • lower stomach (abdominal) pain
  • tiredness
  • headache
  • dizziness
  • breast pain
  • vomiting
Section 50569-3

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 73436-2859-1

Morning After Pill TM

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

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 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 1.5 mg

Other Information
  • read the instructions, warnings, and enclosed product leaflet before use
  • do not use if 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 1-877-862-7455

Monday - Friday 8 AM - 5 PM CST or visit us at cadenceotc.com

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)

Manufactured for:

Cadence OTC

Oakland CA, 94612

NDC 73436-2859-1



Product made in Germany

Issued: September 2023

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
  • nausea
  • lower stomach (abdominal) pain
  • tiredness
  • headache
  • dizziness
  • breast pain
  • vomiting
Section 50569-3 (50569-3)

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 73436-2859-1

Morning After Pill TM

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

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 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 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 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 1-877-862-7455

Monday - Friday 8 AM - 5 PM CST or visit us at cadenceotc.com

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)