Her Style™ (levonorgestrel Tablet, 1.5mg)

Her Style™ (levonorgestrel Tablet, 1.5mg)
SPL v3
SPL
SPL Set ID 6e631755-b7c5-4a3a-b46d-f66b4ceedb1c
Route
ORAL
Published
Effective Date 2022-10-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levonorgestrel (1.5 mg)
Inactive Ingredients
Magnesium Stearate Lactose Monohydrate Starch, Pregelatinized Corn Polyvinyl Alcohol Titanium Dioxide Talc Polyethylene Glycol 3350 Lecithin, Soybean Fd&c Red No. 40 Fd&c Yellow No. 6 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: 15 Shape: round Color: pink Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2022-11-30

Description

Levonorgestrel 1.5mg

Purpose

Emergency contraception


Medication Information

Purpose

Emergency contraception

Description

Levonorgestrel 1.5mg

Use

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

Warnings

Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrel or any other ingredients in Her Style.

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 birth control

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.

When using this product you may have

• menstrual changes

• nausea

• lower stomach (abdominal) pain

• tiredness

• headache

• dizziness

• breast pain

• vomiting

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

Her Style™

(levonorgestrel Tablet) 1.5 mg

Emergency Contraceptive

One Tablet. One Dose.

Active Ingredient

Levonorgestrel 1.5mg

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° to 25°C  (68° to 77°F).

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: magnesium stearate, lactose monohydrate, pregelatinized starch, polyvinyl alcohol, titanium dioxide, talc, macrogol/PEG, lecithin (soya), FD&C red#40 aluminum lake, FD&C yellow#6 aluminum lake, FD&C blue#1 aluminum lake.

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 for:  Ingenus Pharmaceuticals LLC

Orlando, FL 32839-6408

Made in China.

I0173

Rev. A

Iss. 10/2022

Inactive Ingredient

magnesium stearate, lactose monohydrate, pregelatinized starch, polyvinyl alcohol, titanium dioxide, talc, macrogol/PEG, lecithin (soya), FD&C red#40 aluminum lake, FD&C yellow#6 aluminum lake, FD&C blue#1 aluminum lake.

What You Need to Know

Her Style™ 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.

Questions Or Comments?

For more information or to speak to a healthcare professional, call: 1-877-748-1970.

(Monday-Friday, 9am to 5pm)

What Her Style™ Is Not.

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

How Does Her Style™ Work?

Her Style™ is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Her Style™ 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 Her Style™ 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). 

Keep Out of Reach of Children

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

When Not to Use Her Style™.

Her Style™ 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 Her Style™.

How Effective Is Her Style™?

If Her Style™ 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.

When Should I Use Her Style™?

The sooner you take emergency contraception, the better it works. You should use Her Style™ within 72 hour s (3 days) after you have had unprotected sex.

Her Style™ 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

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, Her Style™ 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.

How Will I Know Her Style™ Worked?

You will know Her Style™ 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.

Package Label.principal Display Panel
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 Her Styleand increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.

How Can I Get the Best Results From Her Style™?

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

What If I Still Have Questions About Her Style™?

If you have questions or need more information, call our toll-free number, 1-877-748-1970.


Structured Label Content

Use (USE)

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

Purpose (PURPOSE)

Emergency contraception

Warnings (WARNINGS)

Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrel or any other ingredients in Her Style.

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 birth control

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.

When using this product you may have

• menstrual changes

• nausea

• lower stomach (abdominal) pain

• tiredness

• headache

• dizziness

• breast pain

• vomiting

Directions (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

Her Style™

(levonorgestrel Tablet) 1.5 mg

Emergency Contraceptive

One Tablet. One Dose.

Active Ingredient (ACTIVE INGREDIENT)

Levonorgestrel 1.5mg

Other Information (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° to 25°C  (68° to 77°F).

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: magnesium stearate, lactose monohydrate, pregelatinized starch, polyvinyl alcohol, titanium dioxide, talc, macrogol/PEG, lecithin (soya), FD&C red#40 aluminum lake, FD&C yellow#6 aluminum lake, FD&C blue#1 aluminum lake.

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 for:  Ingenus Pharmaceuticals LLC

Orlando, FL 32839-6408

Made in China.

I0173

Rev. A

Iss. 10/2022

Inactive Ingredient (INACTIVE INGREDIENT)

magnesium stearate, lactose monohydrate, pregelatinized starch, polyvinyl alcohol, titanium dioxide, talc, macrogol/PEG, lecithin (soya), FD&C red#40 aluminum lake, FD&C yellow#6 aluminum lake, FD&C blue#1 aluminum lake.

What You Need to Know

Her Style™ 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.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

For more information or to speak to a healthcare professional, call: 1-877-748-1970.

(Monday-Friday, 9am to 5pm)

What Her Style™ Is Not. (What Her Style™ is not.)

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

How Does Her Style™ Work? (How does Her Style™ work?)

Her Style™ is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Her Style™ 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 Her Style™ 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). 

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.

When Not to Use Her Style™. (When not to use Her Style™.)

Her Style™ 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 Her Style™.

How Effective Is Her Style™? (How effective is Her Style™?)

If Her Style™ 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.

When Should I Use Her Style™? (When should I use Her Style™?)

The sooner you take emergency contraception, the better it works. You should use Her Style™ within 72 hour s (3 days) after you have had unprotected sex.

Her Style™ 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

Will I Experience Any Side Effects? (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, Her Style™ 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.

How Will I Know Her Style™ Worked? (How will I know Her Style™ worked?)

You will know Her Style™ 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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)
When Should I Talk to A Doctor Or Pharmacist? (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 Her Styleand increase your chance of becoming pregnant. Your doctor may prescribe another form of emergency contraception that may not be affected by these medications.

How Can I Get the Best Results From Her Style™? (How can I get the best results from Her Style™?)

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

What If I Still Have Questions About Her Style™? (What if I still have questions about Her Style™?)

If you have questions or need more information, call our toll-free number, 1-877-748-1970.


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Raw Label Data

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