Ithappenztm

Ithappenztm
SPL v3
SPL
SPL Set ID 5ee40793-0121-4b8f-b20d-3178bbe262e2
Route
ORAL
Published
Effective Date 2025-04-07
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Levonorgestrel (1.5 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Lactose Monohydrate Magnesium Stearate Starch, Potato Talc

Identifiers & Packaging

Pill Appearance
Imprint: S;11 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2022-11-14

Description

Active ingredient (in each tablet) Levonorgestrel USP 1.5 mg

Purpose

Emergency contraceptive

Patient Information

ITHAPPENZ TM MORNING AFTER (levonorgestrel tablet 1.5 mg) Emergency Contraceptive One Tablet. One Step. What You Need to Know What is  ITHAPPENZ TM MORNING AFTER ? ITHAPPENZ TM MORNING AFTER   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  ITHAPPENZ TM MORNING AFTER is not. ITHAPPENZ TM MORNING AFTER   will not work if you are already pregnant and will not affect an existing pregnancy. ITHAPPENZ TM MORNING AFTER   will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs). When should I use ITHAPPENZ TM MORNING AFTER ? The sooner you take emergency contraception, the better it works. You should use ITHAPPENZ TM MORNING AFTER   within 72 hours (3 days) after you have had unprotected sex . ITHAPPENZ TM MORNING AFTER 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 ITHAPPENZ TM MORNING AFTER . ITHAPPENZ TM MORNING AFTER 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 ITHAPPENZ TM MORNING AFTER. When should I talk to a doctor or 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  ITHAPPENZ TM MORNING AFTER and increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications. How does  ITHAPPENZ TM MORNING AFTER  work? ITHAPPENZ TM MORNING AFTER works before release of an egg from the ovary. As a result, ITHAPPENZ TM MORNING AFTER usually stops or delays the release of an egg from the ovary. ITHAPPENZ TM MORNING AFTER is one tablet that contains a higher dose of levonorgestrel than birth control pills and works in a similar way to prevent pregnancy. How can I get the best results from ITHAPPENZ TM MORNING AFTER ? You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take ITHAPPENZ TM MORNING AFTER , the better it works . How effective is ITHAPPENZ TM MORNING AFTER ? If  ITHAPPENZ TM MORNING AFTER 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  ITHAPPENZ TM MORNING AFTER worked? You will know ITHAPPENZ TM MORNING AFTER 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, ITHAPPENZ TM MORNING AFTER 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  ITHAPPENZ TM MORNING AFTER ? If you have questions or need more information, call our toll-free number AUROHEALTH LLC at 1-855-274-4122. 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° to 25°C (68° to 77°F). Active ingredient: levonorgestrel 1.5 mg Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, and talc. 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. Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 03/2023


Medication Information

Purpose


Emergency contraceptive

Patient Information


ITHAPPENZ TM MORNING AFTER

(levonorgestrel tablet 1.5 mg)

Emergency Contraceptive

One Tablet. One Step.

What You Need to Know

What is ITHAPPENZ TM MORNING AFTER?



ITHAPPENZTM MORNING AFTER 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 ITHAPPENZ TM MORNING AFTER is not.

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



When should I use ITHAPPENZ TM MORNING AFTER?

The sooner you take emergency contraception, the better it works. You should use ITHAPPENZTM MORNING AFTER  within 72 hours (3 days) after you have had unprotected sex .



ITHAPPENZTM MORNING AFTER 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 ITHAPPENZ TM MORNING AFTER.

ITHAPPENZTM MORNING AFTER 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 ITHAPPENZTM MORNING AFTER.


When should I talk to a doctor or 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  ITHAPPENZTM MORNING AFTER and increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.



How does ITHAPPENZ TM MORNING AFTER  work?

ITHAPPENZTM MORNING AFTER works before release of an egg from the ovary. As a result, ITHAPPENZTM MORNING AFTER usually stops or delays the release of an egg from the ovary. ITHAPPENZTM MORNING AFTER is one tablet that contains a higher dose of levonorgestrel than birth control pills and works in a similar way to prevent pregnancy.



How can I get the best results from ITHAPPENZ TM MORNING AFTER?

You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take ITHAPPENZ TM MORNING AFTER, the better it works.



How effective is ITHAPPENZ TM MORNING AFTER?

If  ITHAPPENZTM MORNING AFTER 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 ITHAPPENZ TM MORNING AFTER worked?

You will know ITHAPPENZTM MORNING AFTER 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, ITHAPPENZTM MORNING AFTER 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 ITHAPPENZ TM MORNING AFTER?

If you have questions or need more information, call our toll-free number AUROHEALTH LLC at 1-855-274-4122.



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° to 25°C (68° to 77°F).

Active ingredient: levonorgestrel 1.5 mg



Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, and talc.



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.



Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Manufactured by:

Aurobindo Pharma Limited

Hyderabad-500 032, India



Revised: 03/2023



Description

Active ingredient (in each tablet) Levonorgestrel USP 1.5 mg

Use

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

Section 50567-7

When using this product you may have



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



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

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.
Do Not Use


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

Active ingredient (in each tablet)



Levonorgestrel USP 1.5 mg

Questions?

Call 1-855-274-4122

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

Other Information


  • read the instructions, warnings and enclosed product leaflet before use
  • do not use if carton is open or tear strip is removed or the blister seal is broken or missing
  • store at 20° to 25°C (68° to 77°F)
Inactive Ingredients


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

Keep Out of Reach of Children.


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

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.

Package Label Principal Display Panel 1.5 Mg (1 Tablet Carton Label)

Compare to the                 NDC 58602-892-57

active ingredient

of Plan B One-Step®          



ITHAPPENZTM

MORNING AFTER



levonorgestrel tablet 1.5 mg

emergency contraceptive




•    Reduces chance of pregnancy

       after unprotected sex.

•    Not for regular birth control.



1 Tablet

One Tablet. One Stop.



Levonorgestrel 1.5 mg
















Structured Label Content

Use

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

Section 50567-7 (50567-7)

When using this product you may have



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


Emergency contraceptive

Warnings



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

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.
Do Not Use (Do not use)


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

Active ingredient (in each tablet)



Levonorgestrel USP 1.5 mg

Questions?

Call 1-855-274-4122

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

Other Information (Other information)


  • read the instructions, warnings and enclosed product leaflet before use
  • do not use if carton is open or tear strip is removed or the blister seal is broken or missing
  • store at 20° to 25°C (68° to 77°F)
Patient Information


ITHAPPENZ TM MORNING AFTER

(levonorgestrel tablet 1.5 mg)

Emergency Contraceptive

One Tablet. One Step.

What You Need to Know

What is ITHAPPENZ TM MORNING AFTER?



ITHAPPENZTM MORNING AFTER 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 ITHAPPENZ TM MORNING AFTER is not.

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



When should I use ITHAPPENZ TM MORNING AFTER?

The sooner you take emergency contraception, the better it works. You should use ITHAPPENZTM MORNING AFTER  within 72 hours (3 days) after you have had unprotected sex .



ITHAPPENZTM MORNING AFTER 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 ITHAPPENZ TM MORNING AFTER.

ITHAPPENZTM MORNING AFTER 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 ITHAPPENZTM MORNING AFTER.


When should I talk to a doctor or 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  ITHAPPENZTM MORNING AFTER and increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.



How does ITHAPPENZ TM MORNING AFTER  work?

ITHAPPENZTM MORNING AFTER works before release of an egg from the ovary. As a result, ITHAPPENZTM MORNING AFTER usually stops or delays the release of an egg from the ovary. ITHAPPENZTM MORNING AFTER is one tablet that contains a higher dose of levonorgestrel than birth control pills and works in a similar way to prevent pregnancy.



How can I get the best results from ITHAPPENZ TM MORNING AFTER?

You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take ITHAPPENZ TM MORNING AFTER, the better it works.



How effective is ITHAPPENZ TM MORNING AFTER?

If  ITHAPPENZTM MORNING AFTER 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 ITHAPPENZ TM MORNING AFTER worked?

You will know ITHAPPENZTM MORNING AFTER 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, ITHAPPENZTM MORNING AFTER 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 ITHAPPENZ TM MORNING AFTER?

If you have questions or need more information, call our toll-free number AUROHEALTH LLC at 1-855-274-4122.



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° to 25°C (68° to 77°F).

Active ingredient: levonorgestrel 1.5 mg



Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, and talc.



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.



Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Manufactured by:

Aurobindo Pharma Limited

Hyderabad-500 032, India



Revised: 03/2023



Inactive Ingredients (Inactive ingredients)


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

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 (1-800-222-1222)  right away.

Ask A Doctor Or Pharmacist Before Use If You Are (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.

Package Label Principal Display Panel 1.5 Mg (1 Tablet Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -1.5 mg (1 Tablet Carton Label))

Compare to the                 NDC 58602-892-57

active ingredient

of Plan B One-Step®          



ITHAPPENZTM

MORNING AFTER



levonorgestrel tablet 1.5 mg

emergency contraceptive




•    Reduces chance of pregnancy

       after unprotected sex.

•    Not for regular birth control.



1 Tablet

One Tablet. One Stop.



Levonorgestrel 1.5 mg
















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Raw Label Data

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