FDA Label for Levonorgestrel
View Indications, Usage & Precautions
Levonorgestrel Product Label
The following document was submitted to the FDA by the labeler of this product Naari Pte Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Manufactured for:
Naari Pte Limited
36 Robinson Road, #13-06
City House, Singapore 068877
NDC 79929-016-01
Rev.January 2023
Active Ingredient
Levonorgestrel 1.5 mg
Purpose
Emergency contraceptive
Use
for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
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
Otc - Ask Doctor/Pharmacist
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.
Otc - When Using
When using this product you may have
- menstrual changes
- tiredness
- breast pain
- nausea
- headache
- vomiting
- lower stomach (abdominal) pain
- dizziness
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control center right away.
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
Other Information
- read the instructions, warnings and enclosed product leaflet before use
- do not use if carton is open or tear strip is removed or blister seal is broken or missing
- store at 20-25°C (68-77°F)
Inactive Ingredients
colloidal anhydrous silica, corn starch, lactose monohydrate, magnesium stearate, potato starch and purified talc
Questions?
If you have questions or need more information, call our toll-free number, x-xxx-xxx-xxxx.
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FOR CLINIC USE ONLY.
NOT FOR RETAIL SALE.
NDC 79929-016-01
levonorgestrel 1.5 mg
emergency contraceptive
Reduces chance of
pregnancy after
unprotected sex.
Not for regular birth control.
One Tablet.
One Step.
1 Tablet Levonorgestrel 1.5 mg
* Please review the disclaimer below.