SPL v1
SPL
SPL Set ID 0167c34f-4a91-d0f9-e063-6294a90a96d3
Route
ORAL
Published
Effective Date 2023-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 718 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2023-08-25

Description

Levonorgestrel, USP 1.5 mg

Purpose

Emergency Contraceptive


Medication Information

Purpose

Emergency Contraceptive

Description

Levonorgestrel, USP 1.5 mg

Use

for women to reduce chance of pregnancy af ter unprotected sex (if a contraceptive failed or if you did not use bir th control)

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).

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

• 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 after taking the medication, call a healthcare professional to find out if you should repeat the dose

Questions?

Call 1-800-397-0670

Active Ingredient

Levonorgestrel, USP 1.5 mg

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 carton is open or tear strip is removed or blister seal is broken or missing

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

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

Principal Display Panel

NDC 83567-7003-5

*Compare to the active ingredient of Plan B One-Step ®

EMPOWERED CHOICE TM

Levonorgestrel Tablet 1.5 mg

Emergency Contraceptive

1 Tablet Levonorgestrel 1.5 mg

One Tablet. One Step.

  • Reduces the chance of pregnancy after unprotected sex
  • Not for regular birth control
  • 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

Spl Unclassified Section

Distributed by:

Versea Diagnostics, LLC

Tampa, FL 33602


Structured Label Content

Use (USE)

for women to reduce chance of pregnancy af ter unprotected sex (if a contraceptive failed or if you did not use bir th control)

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).

Purpose (PURPOSE)

Emergency Contraceptive

Warnings (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

• tiredness

• breast pain

• nausea

• headache

• vomiting

• lower stomach (abdominal) pain

• dizziness

Directions (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

Questions? (QUESTIONS?)

Call 1-800-397-0670

Active Ingredient (ACTIVE INGREDIENT)

Levonorgestrel, USP 1.5 mg

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 carton is open or tear strip is removed or blister seal is broken or missing

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 83567-7003-5

*Compare to the active ingredient of Plan B One-Step ®

EMPOWERED CHOICE TM

Levonorgestrel Tablet 1.5 mg

Emergency Contraceptive

1 Tablet Levonorgestrel 1.5 mg

One Tablet. One Step.

  • Reduces the chance of pregnancy after unprotected sex
  • Not for regular birth control
  • 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

Spl Unclassified Section (SPL UNCLASSIFIED SECTION)

Distributed by:

Versea Diagnostics, LLC

Tampa, FL 33602


Advanced Ingredient Data


Raw Label Data

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