Afterpill®

Afterpill®
SPL v6
SPL
SPL Set ID 4d284ba4-9cd7-48e4-95b9-cd6d0367bfd1
Route
ORAL
Published
Effective Date 2023-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levonorgestrel (1.5 mg)
Inactive Ingredients
Lactose Monohydrate Magnesium Stearate Povidone K30 Silicon Dioxide Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: LU;S25 Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2017-09-14

Description

Levonorgestrel USP 1.5 mg

Purpose

Emergency contraceptive


Medication Information

Purpose

Emergency contraceptive

Description

Levonorgestrel USP 1.5 mg

Section 42229-5

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.

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).
  • tablet is enclosed in wallet seal. Do not use if the wallet seal is broken .
  • store at 25°C (77°C); excursions permitted to 15 to 30°C (59 to 86°C) [see USP Controlled Room temperature].
Section 50565-1

Keep out of the reach of children.

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

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

Do not use

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

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.

When using this product you may have

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

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

Active Ingredient

Levonorgestrel USP 1.5 mg

Inactive Ingredients

colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and povidone.

When Should I Use Afterpill?

The sooner you take emergency contraception, the better it works. You should use AfterPill within 72 hours (3 days) after you have had unprotected sex .

AfterPill is a backup or emergency method of birth control you can use when:

  • your regular birth control was used incorrectly or failed
  • you did not use any birth control method
Package Label.principal Display Panel

AfterPill® (levonorgestrel) Tablet, 1.5 mg

NDC 64122-605-01

Wallet Label: 1 Tablet


Structured Label Content

Section 42229-5 (42229-5)

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.

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).
  • tablet is enclosed in wallet seal. Do not use if the wallet seal is broken .
  • store at 25°C (77°C); excursions permitted to 15 to 30°C (59 to 86°C) [see USP Controlled Room temperature].
Section 50565-1 (50565-1)

Keep out of the reach of children.

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

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

Do not use

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

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.

When using this product you may have

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

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

Active Ingredient

Levonorgestrel USP 1.5 mg

Inactive Ingredients

colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and povidone.

When Should I Use Afterpill? (When should I use AfterPill?)

The sooner you take emergency contraception, the better it works. You should use AfterPill within 72 hours (3 days) after you have had unprotected sex .

AfterPill is a backup or emergency method of birth control you can use when:

  • your regular birth control was used incorrectly or failed
  • you did not use any birth control method
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

AfterPill® (levonorgestrel) Tablet, 1.5 mg

NDC 64122-605-01

Wallet Label: 1 Tablet


Advanced Ingredient Data


Raw Label Data

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