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0cdf198e-c114-b9fa-e063-6294a90a566a
HUMAN OTC DRUG LABEL
Aug 27, 2025
Winx Health Inc.
DUNS: 117116737
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levonorgestrel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (7)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- 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
**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).
Colloidal Silicon Dioxide, Corn Starch, Lactose Monohydrate, Magnesium Dtearate, Povidone
For women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
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).
Emergency Contraceptive
Levonorgestrel 1.5 mg