FDA Label for Next Choice One Dose

View Indications, Usage & Precautions

Next Choice One Dose Product Label

The following document was submitted to the FDA by the labeler of this product Foundation Consumer Healthcare Llc. 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 by:
Gedeon Richter, Ltd, Budapest, Hungary


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



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
  • 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 tear strip is removed or blister seal is broken or missing
  • store at 20-25°C (68-77°F)

Inactive Ingredients



colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc


Questions?



Call 1-888-919-0780


Principal Display Panel - 1.5 Mg Tablet Blister Pack Box



NDC 69536-133-88

One Tablet, One Dose

Next Choice
ONE DOSE®

Levonorgestrel 1.5 mg

Emergency Contraceptive

Reduces the chance of pregnancy after unprotected sex.

Not for regular birth control.

1
Tablet
Levonorgestrel 1.5 mg


* Please review the disclaimer below.