Nest Choice-One Dose Levonorgestrel Tablet

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2017-08-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:12:42

Label at a glance#

ProductNext Choice One Dose
Active ingredientLEVONORGESTREL
Label structure11 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Levonorgestrel 1.5 mg

Purpose

OTC - PURPOSE SECTION

Emergency contraceptive

Use

INDICATIONS & USAGE SECTION

for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Warnings

WARNINGS SECTION

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.

SPL UNCLASSIFIED SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product you may have

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

vomiting


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY 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).
  • 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].

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

CONSUMER INFORMATION

OTHER SAFETY INFORMATION

Next Choice ONE DOSE ®  (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 Dose ®?

Next Choice One Dose ®is 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 Dose ®  is not.

Next Choice One Dose ®   will not work if you are already pregnant and will not affect an existing pregnancy.   Next Choice One Dose ® 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 Dose ® ?

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

Next Choice One Dose ®   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 Dose ® ?

Next Choice One Dose ® should 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 Dose ®.  

How does Next Choice One Dose ® work?

Next Choice One Dose ® is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Next Choice One Dose ® contains 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 Dose ® may 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 Dose ® ?

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 Dose ® , the better it works.   

How effective is Next Choice One Dose ® ?

If Next Choice One Dose ® is 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 Dose ® worked?

You will know Next Choice One Dose ® has 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 Dose ® is 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 Dose ® ?

If you have questions or need more information, call our toll-free number, 1-866-992-8766, or visit Actavis’s My Next Choice One Dose ® Website.  

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:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA 

Phone: 1-866-992-8766

www.mynextchoiceonedose.com

Revised: October 2014

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52544-065-54EA - Each52544-065e9658699-0d71-45ae-84b5-e482343d2b5212014-08-01

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-164268071-1642-1
52544-065

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
968bf634-dc38-39da-e053-2995a90a55fa575d7afb-b735-fe99-e053-2991aa0aea712019-11-04WarningsExact identifier
spl set id: 575d7afb-b735-fe99-e053-2991aa0aea71

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.