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Next Choice One Dose

Watson Pharma, Inc.

Next Choice - One Dose™ (Levonorgestrel) Tablet 1.5 mg




FULL PRESCRIBING INFORMATION

Drug Facts

Levonorgestrel 1.5 mg

Emergency contraceptive

for women 17 years of age and older 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.
Note: Contains FD&C Yellow No. 6 as a color additive.

Sexually transmitted diseases (STDs) alert:
This product does not protect agains HIV/AIDS or other STDs

  • if you are already pregnant (because it will not work)
  • for regular birth control

you may have

 
  •  
  menstrual changes  
  •  
  headache
 
  •  
  nausea  
  •  
  dizziness
  •  
 lower stomach (abdominal) pain
  •  
 breast pain
 
  •  
  tiredness  
  •  
  vomiting  
  

In case of overdose, get medical help or contact a Poison Control center right away.

  • women 17 years of age or older:
    • 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
  • 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).
  • tablet is enclosed in a blister seal.  Do not use if carton is open or the blister seal is broken or missing.
  • store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

colloidal silicon dioxide, corn starch, FD&C Yellow #6, lactose monohydrate, magnesium stearate, povidone.

Call 1-866-9WATSON (1-866-992-8766) or Web Site at www.mynextchoiceonedose.com

CONSUMER INFORMATION
Next Choice ONE DOSETM (Levonorgestrel Tablet, 1.5 mg)
Emergency Contraceptive
One Tablet. One Dose.
What You Need to Know

Contains FD&C Yellow #6 as a color additive.

What is Next Choice One DoseTM?

Next Choice One DoseTMis emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex. It is a backup method of preventing pregnancy and should not be used as regular birth control. 

What Next Choice One DoseTM  is not.

Next Choice One DoseTM   will not work if you are already pregnant and will not affect an existing pregnancy.   Next Choice One DoseTM will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).

When should I use Next Choice One DoseTM ?

The sooner you take emergency contraception, the better it works. You should use  Next Choice One DoseTMwithin 72 hours (3 days) after you have had unprotected sex.

Next Choice One DoseTM   is a backup or emergency method of birth control you can use when:

  • your regular birth control was used incorrectly or failed
  • you did not use any birth control method

When not to use Next Choice One DoseTM ?

Next Choice One DoseTMshould not be used:

  • as a regular birth control method, because it’s not as effective as regular birth control.
  • if you are already pregnant, because it will not work.
  • if you are allergic to levonorgestrel or any other ingredients in Next Choice One DoseTM.

How does Next Choice One DoseTM work?

Next Choice One DoseTMis one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Next Choice One DoseTMcontains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that Next Choice One DoseTMmay also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).

How can I get the best results from Next Choice One DoseTM ?

You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex.  The sooner you take Next Choice One DoseTM , the better it works.

How effective is Next Choice One DoseTM ?

If Next Choice One DoseTMis taken as directed, it can significantly decrease the chance that you will get pregnant. About 7 out of every 8 women who would have gotten pregnant will not become pregnant.

How will I know if Next Choice One DoseTM worked?

You will know Next Choice One DoseTMhas been effective when you get your next period, which should come at the expected time, or within a week of the expected time. If your period is delayed beyond 1 week, it is possible you may be pregnant. You should get a pregnancy test and follow up with your healthcare professional.

Will I experience any side effects?

  • some women may have changes in their period, such as a period that is heavier or lighter or a period that is early or late. If your period is more than a week late, you may be pregnant.
  • if you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention.
  • when used as directed, Next Choice One DoseTMis safe and effective. Side effects may include changes in your period, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, and breast tenderness.
  • if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose.

What if I still have questions about Next Choice One DoseTM ?

If you have questions or need more information, call our toll-free number, 1-866-9WATSON      (1-866-992-8766), or visit Watson’s My Next Choice One DoseTMWeb Site.

Other Information

Keep out of reach of children:

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Tablet is enclosed in a blister seal. Do not use if carton is open or the blister seal is broken or missing.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Active ingredient: levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Yellow #6, lactose monohydrate, magnesium stearate, povidone.

If you are sexually active, you should see a healthcare provider for routine checkups. Your

healthcare provider will talk to you about and, if necessary, test you for sexually transmitted diseases, teach you about effective methods of routine birth control, and answer any other questions you may have.

Manufactured by:
Watson Laboratories, Inc.
Corona, CA 92880 USA

Distributed by:
Watson Pharma, Inc.
Parsippany, NJ 07054 USA

Phone: 1-866-9WATSON (1-866-992-8766)
www.mynextchoiceonedose.com

Revised: March 2014

NDC 52544-065-54

NEW!
Now Available Over The Counter
One Tablet, One Dose

Nex Choice
One Dose
(Levonorgestrel)
Tablet 1.5 mg

Emergency Contraceptive

The sooner you take it, the more effective it will be
Take as soon as possible within 72 hour (3 days)
after unprotected sex

Will not harm an existing pregnancy

Reduces the change of pregnancy after
unprotected sex.

Not for regular birth control.

1 Tablet Levonorgestrel, 1.5 mg

Next Choice One Dose

Next Choice One Dose

Levonorgestrel TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52544-065
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LEVONORGESTREL LEVONORGESTREL 1.5 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
FD&C YELLOW NO. 6
lactose monohydrate
MAGNESIUM STEARATE
POVIDONES

Product Characteristics

Color Size Imprint Code Shape
ORANGE (Peach) 6 mm WATSON;287 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:52544-065-54 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200670 2014-05-12


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Be sure to consult your doctor before taking any medication!
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