Levonorgestrel

LEVONORGESTREL ORAL HUMAN OTC DRUG

Levonorgestrel is an FDA drug label for the active ingredient LEVONORGESTREL manufactured by Xiromed LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230905.

Generic name
LEVONORGESTREL
Manufacturer
Xiromed LLC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
70700-164
Application
ANDA205329
Label effective
20230905

Active ingredients

Active ingredient Levonorgestrel 1.5 mg

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

When should I use levonorgestrel tablet 1.5 mg? The sooner you take emergency contraception, the better it works. You should use levonorgestrel tablet 1.5 mg within 72 hours (3 days) after you have had unprotected sex. Levonorgestrel tablet 1.5 mg 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

Contraindications

Not available.

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

Adverse Reactions

Not available.

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