SPL v6
SPL
SPL Set ID 0cdf198e-c114-b9fa-e063-6294a90a566a
Route
ORAL
Published
Effective Date 2024-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 17 Shape: round Color: orange Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2024-10-08

Description

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


Medication Information

Warnings and Precautions

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

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).

Indications and Usage

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

Dosage and Administration
  • 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
Description

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

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 51727-6

Colloidal Silicon Dioxide, Corn Starch, Lactose Monohydrate, Magnesium Dtearate, Povidone

Section 51945-4

Section 55105-1

Emergency Contraceptive

Section 55106-9

Levonorgestrel 1.5 mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)
  • 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
Warnings and Precautions (34071-1)

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

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 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 51727-6 (51727-6)

Colloidal Silicon Dioxide, Corn Starch, Lactose Monohydrate, Magnesium Dtearate, Povidone

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Emergency Contraceptive

Section 55106-9 (55106-9)

Levonorgestrel 1.5 mg


Advanced Ingredient Data


Raw Label Data

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