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  5. Label Information: My Choice Tm

FDA Label for My Choice Tm

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. ALLERGY ALERT
    6. SEXUALLY TRANSMITTED DISEASES (STDS) ALERT
    7. DO NOT USE
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 1.5 MG TABLET BLISTER PACK CARTON

My Choice Tm Product Label

The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. 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

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

Relabeled by:

Proficient Rx Lp

Thousand Oaks, CA 91320


Active Ingredient



Levonorgestrel, USP 1.5 mg


Purpose



Emergency contraceptive


Use



for women to reduce chance of pregnancy af ter unprotected sex (if a contraceptive failed or if you did not use bir th 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 bir th 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
  • •dizziness
  • •nausea
  • •headache
  • •breast pain
  • •lower stomach (abdominal) pain
  • •vomiting

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 fer tilization of a released egg (joining of sperm and egg) or at tachment of a fer tilized 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° to 25°C (68° to 77°F)

Inactive Ingredients



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


Questions Or Comments?



For more information, call toll free 1-800-818-4555 weekdays


Principal Display Panel - 1.5 Mg Tablet Blister Pack Carton



†Compare To
the active ingredient of
Plan B One-Step®

NDC 71205-120-01

See New Warning

My
Choice™

Levonorgestrel Tablet 1.5 mg
Emergency Contraceptive

  • •Reduces the chance of pregnancy after unprotected sex
  • •Not for regular birth control
  • •The sooner you take it, the more effective it will be
  • •Take as soon as possible within 72 hours (3 days)
    after unprotected sex
  • •Will not harm an existing pregnancy

    • 1 Tablet Levonorgestrel 1.5 mg

    One Tablet. One Step.


* Please review the disclaimer below.