Drugplain

LEADER Emergency Contraceptive Levonorgestrel 1.5 mg/1

levonorgestrel · TABLET · Cardinal Health 110, LLC. DBA Leader

No Recall History
Plain English

Leader Emergency Contraceptive is an over-the-counter tablet containing levonorgestrel, a progestin used to prevent pregnancy after unprotected intercourse or contraceptive failure. It works best when taken as soon as possible after unprotected sexual contact.

Key Facts

Brand Name
LEADER Emergency Contraceptive Levonorgestrel
Generic Name
levonorgestrel
NDC Code (Product)
70000-0600
Manufacturer
Cardinal Health 110, LLC. DBA Leader
Strength
1.5 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA202635
Drug Class
Progestin [EPC]; Progestin-containing Intrauterine System [EPC]
Marketing Start
03/22/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective450 reports
nausea195 reports
headache174 reports
genital haemorrhage160 reports
abdominal pain133 reports
dizziness129 reports
fatigue127 reports
maternal exposure during pregnancy122 reports
vaginal haemorrhage118 reports
vomiting111 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

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 dizziness nausea headache breast pain lower stomach (abdominal) pain vomiting 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).

Frequently Asked Questions

What is LEADER Emergency Contraceptive Levonorgestrel used for?

Leader Emergency Contraceptive is an over-the-counter tablet containing levonorgestrel, a progestin used to prevent pregnancy after unprotected intercourse or contraceptive failure. It works best when taken as soon as possible after unprotected sexual contact.

Is LEADER Emergency Contraceptive Levonorgestrel a controlled substance?

LEADER Emergency Contraceptive Levonorgestrel is not classified as a controlled substance by the DEA.

What is the generic name for LEADER Emergency Contraceptive Levonorgestrel?

The generic name for LEADER Emergency Contraceptive Levonorgestrel is levonorgestrel. There are 12 other brand versions of levonorgestrel.

What is the NDC code for LEADER Emergency Contraceptive Levonorgestrel 1.5 mg/1?

The NDC (National Drug Code) for LEADER Emergency Contraceptive Levonorgestrel 1.5 mg/1 is 70000-0600, listed by Cardinal Health 110, LLC. DBA Leader.

Product NDC

70000-0600

Package NDC

70000-0600-1

Other Levonorgestrel Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)