Postday One-step Tablet
FDA Label NDC 85506-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Home Health Brands, Llc for the product Postday One-step (NDC 85506-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
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 • 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. (1-800-222-1222)
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
• this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation).
• do not use if carton is open or the blister seal is broken or missing
• store at 20-25°C (68° to 77°F)
Inactive Ingredients
silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc
Questions?
Call 833-337-6872
Packaging
Postday One-step (85506100 2)
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