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Plan B One-Step by Central Texas Community Health Centers

Dosage form: tablet
Ingredients: LEVONORGESTREL 1.5mg
Labeler: Central Texas Community Health Centers
NDC Code: 76413-323

Plan B One-Step

Drug Facts

Active ingredient

Levonorgestrel 1.5mg

Purpose

Emergency contraceptive

Indications

Use for women to reduce 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

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

When using this product you may have
  • menstrual changes
  • nausea
  • lower stomach (abdominal) pain
  • tiredness
  • headache
  • dizziness
  • breast pain
  • vomiting

Keep out of reach of children.

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

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

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 tear strip is removed 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, potato starch, talc

Plan B One-Step®
Emergency Contraceptive
One Tablet. One Step.
What You Need to Know

What is Plan B One-Step®?

Plan B One-Step® 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 Plan B One-Step® is not.

Plan B One-Step® will not work if you are already pregnant and will not affect an existing pregnancy. Plan B One-Step® will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).

When should I use Plan B One-Step®?

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

Plan B One-Step® 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 Plan B One-Step®.

Plan B One-Step® 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 Plan B One-Step®.

How does Plan B One-Step® work?

Plan B One-Step® is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Plan B One-Step® 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 Plan B One-Step® 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 Plan B One-Step®?

You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take Plan B One-Step®, the better it works.

How effective is Plan B One-Step®?

If Plan B One-Step® 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 Plan B One-Step® worked?

You will know Plan B One-Step® 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, Plan B One-Step® 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.

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, potato starch, magnesium stearate, talc, corn starch, lactose monohydrate

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.

Printed in USA

PRINCIPAL DISPLAY PANEL - 1.5 mg Tablet Blister Pack Carton Label

CommUnityCare Federally Qualified Health Centers

Plan B
1.5mg

Date:

Name:
Dr.

TAKE 1 TAB WITHIN 3 DAYS (72 hours) AFTER UNPROTECTED
SEX.

123456

1/1/01

Plan B (Levonorgestrel) 1.5MG #1 TAB NDC 76413-323-01

Batch: 123456
Lot: 123456
Exp: 1/1/01
TEVA

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

PLAN B ONE-STEP 
levonorgestrel tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-323(NDC:51285-146)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL1.5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STARCH, POTATO 
MAGNESIUM STEARATE 
TALC 
STARCH, CORN 
LACTOSE MONOHYDRATE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeG00
Contains    
Packaging
#Item CodePackage Description
1NDC:76413-323-011 BLISTER PACK in 1 CARTON
11 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02199812/12/2013
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIOperations
Central Texas Community Health Centers079674019REPACK(76413-323), RELABEL(76413-323)

Revised: 04/2016
 
Central Texas Community Health Centers

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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