PLAN B ONE-STEP- levonorges trel tablet
Central Texas Community Health Centers
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Plan B One-Step
Drug Facts
Active ingredient
Levonorgestrel 1.5 mg
Purpos e
Emergency contraceptive
Us e
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 trans mitted diseas es (STDs ) alert: This product does not protect against HIV/AIDS or
other STDs
Do not use
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As k a doctor or pharmacist before us e 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 us ing this product you may have
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Keep out of reach of children.
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if you are already pregnant (because it will not work)
for regular birth control
menstrual changes
nausea
lower stomach (abdominal) pain
tiredness
headache
dizziness
breast pain
vomiting
In case of overdose, get medical help or contact a Poison Control center right away.
Directions
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Other information
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Inactive ingredients
colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc
Ques tions?
Call 1-800-330-1271 or visit www.PlanBOneStep.com
CONSUMER INFORMATION
Plan B One-Step
Emergency Contraceptive
One Tablet. One Step.
What You Need to Know
Plan B One-Step Logo
Teva Women’s Health, Inc.
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 s hould I us e 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.
take as s oon as pos sible within 72 hours (3 days ) after unprotected s ex. The s ooner you
take it the better it will work.
if you vomit within 2 hours after taking the medication, call a healthcare profes sional to find
out if you should repeat the dos e
read the instructions , warnings and enclos ed 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 s trip is removed or blis ter s eal is broken or mis s ing.
store at 20-25ºC (68-77ºF)
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Plan B One-Step is a backup or emergency method of birth control you can use when:
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When not to use Plan B One-Step .
Plan B One-Step should not be used:
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When s hould 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 Plan B One-Step 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 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 bes t res ults from Plan B One-Step ?
You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex.
The s ooner 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 s ide effects?
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your regular birth control was used incorrectly or failed
you did not use any birth control method
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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 .
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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.
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What if I still have ques tions about Plan B One-Step ?
If you have questions or need more information, call our toll-free number, 1-800-330-1271, or visit our
website at www.PlanBOneStep.com.
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 blis ter s eal 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 s exually active, you s hould see a healthcare provider for routine checkups . Your
healthcare provider will talk to you about and, if neces s ary, tes t you for s exually trans mitted
diseas es , teach you about effective methods of routine birth control, and answer any other
ques tions you may have.
©2017 Teva Women’s Health, Inc.
Plan B One-Step
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.
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if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if
you should repeat the dose.
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1-800-330-1271 www.PlanBOneStep.com
Manufacturer logo lock up PBOS logo lock up
Rev. 7/2017 Printed in USA
PLAN B ONE-STEP
levonorgestrel tablet
Product Information
Prod uct T yp e
HUMAN OTC DRUG
Ite m Code (S ource )
NDC:76 413-323(NDC:5128 5-146 )
Route of Adminis tration
ORAL
Active Ingredient/Active Moiety
Ing redient Name Basis of Streng th Streng th
LEVO NO RGESTREL (UNII: 5W7SIA7YZW) (LEVO NORGESTREL - UNII:5W7SIA7YZW) LEVONO RGESTREL 1.5 mg
Inactive Ingredients
Ing redient Name Streng th
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
STARCH, PO TATO (UNII: 8 I0 8 9 SAH3T)
MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )
TALC (UNII: 7SEV7J4R1U)
STARCH, CO RN (UNII: O8 232NY3SJ)
LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)
Product Characteristics
Color
WHITE
Score
no sc o re
Shap e
ROUND
Siz e
8 mm
Flavor Imprint Cod e
G0 0
Contains
Packaging
Central Texas Community Health Centers
# Ite m Co de Pac kag e Descriptio n Marketing Start Date Marketing End Date
1 NDC:76 413-323-0 1 1 in 1 CARTON 12/18/20 13
1 1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct
Marketing Information
Marke ting Cate gory Ap plication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date
NDA NDA0 219 9 8 12/18/20 13
Labeler - Central T exas Community Health Centers (079674019)
Establishment
Name Ad dre s s ID/FEI Bus ine s s Op e rations
Travis Co unty He althc are District 79 70 39 39 8 RELABEL(76 413-323) , REPACK(76 413-323)
Revise d: 4/2018
