Label: MORNING AFTER- levonorgestrel tablet

  • NDC Code(s): 69953-514-01
  • Packager: Rapha Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 23, 2019

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Levonorgestrel 1.5 mg

  • Purpose

    Emergency contraceptive

  • Use

    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)

  • Warnings

  • 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

    • 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
  • 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 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, povidone

  • Questions or comments?

    Call 1-800-719-9260

  • Consumer Information

    Levonorgestrel Tablet, 1.5 mg
    Emergency Contraceptive

    One Tablet. One Step.

    What You Need to Know
    What is Levonorgestrel Tablet, 1.5 mg?

    Levonorgestrel Tablet, 1.5 mg 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 Levonorgestrel Tablet, 1.5 mg is not.
    Levonorgestrel Tablet, 1.5 mg will not work if you are already pregnant and will not affect an existing pregnancy. Levonorgestrel Tablet, 1.5 mg will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).

    When should I use Levonorgestrel Tablet, 1.5 mg?
    The sooner you take emergency contraception, the better it works. You should use Levonorgestrel Tablet, 1.5 mg within 72 hours (3 days) after you have had unprotected sex.
    Levonorgestrel Tablet, 1.5 mg 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 Levonorgestrel Tablet, 1.5 mg.
    Levonorgestrel Tablet, 1.5 mg 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 Levonorgestrel Tablet, 1.5 mg.

    How does Levonorgestrel Tablet, 1.5 mg work?
    Levonorgestrel Tablet, 1.5 mg is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Levonorgestrel Tablet, 1.5 mg 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 Levonorgestrel Tablet, 1.5 mg 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 Levonorgestrel Tablet, 1.5 mg?
    You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take Levonorgestrel Tablet, 1.5 mg, the better it works.

    How effective is Levonorgestrel Tablet, 1.5 mg?
    If Levonorgestrel Tablet, 1.5 mg 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 Levonorgestrel Tablet, 1.5 mg worked?
    You will know Levonorgestrel Tablet, 1.5 mg 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, Levonorgestrel Tablet, 1.5 mg 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 Levonorgestrel Tablet, 1.5 mg?
    If you have questions or need more information, call our toll-free number, 1-800-719-9260.

    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.
    Do not use if the blister seal is opened.

    Store at room temperature 20-25°C (68-77°F).

    Active ingredient: levonorgestrel 1.5 mg
    Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone

    1-800-719-9260

    If you are sexually active, you should see a healthcare provider for routine checkups. Your healthcare provider will talk to you about it 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.

    Mfg for Rapha Pharmaceuticals, Inc.
    Orlando, Florida 32819 USA
    Made in India
    : 0C312 MF C1

  • Package/Label Principal Display Panel

    Now Available Over The Counter
    Morning AfterTM

    Levonorgestrel Tablet, 1.5 mg
    emergency contraceptive

    Reduces chance of pregnancy after unprotected sex.

    Not for regular birth control.

    One Tablet
    One Step

    Actual Size

    CONTAINS 1 TABLET LEVONORGESTREL 1.5 MG

    Image

  • INGREDIENTS AND APPEARANCE
    MORNING AFTER 
    levonorgestrel tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69953-514
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL1.5 mg  in 1.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code L0C3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69953-514-011 in 1 CARTON08/21/2016
    11 mg in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20233408/21/2016
    Labeler - Rapha Pharmaceuticals, Inc. (079804155)
    Registrant - Rapha Pharmaceuticals, Inc. (079804155)