Drug Facts
Active ingredient Purpose
Levonorgestrel 1.5 mg.....................Emergency contraceptive
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/A DS 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
■
tiredness
■
breast pain
■
nausea
■
headache
■
vomiting
■
lower stomach (abdominal) pain
■
dizziness
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
Drug Facts (continued)
■
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)
Drug Facts (continued)
Inactive ingredients
colloidal silicon
dioxide, corn starch, lactose monohydrate,
magnesium stearate, potato starch, talc
Questions?
Call 1-800-330-1271 or
visit www.PlanBOneStep.com
1 Tablet Levonorgestrel 1.5 mg
levonorgestrel 1.5 mg
NDC 69536-162-99
emergency on racept ve
On Ta e
t
Reduces chance of
pregnancy after
unprotected sex.
Not for regular birth control.
Visit us at:
www.PlanBOneStep.com
The sooner you
take it, the more
effective it will be
Take as soon as
possible within 72
hours (3 days) after
unprotected sex
Will not harm an
existing pregnancy
O T
O p
emergency
contraceptive
Tab p
Distributed by:
Foundation Consumer
Healthcare, LLC (FCH)
Pittsburgh PA 15205
©2018
Made in Hungary
0 00000 00000 0
80% UPC A
F.P.O.
DRUG FACTS FONT SPECS
DRUG FACTS TITLE ............... 10pt. Hel. Bold Oblique
DRUG FACTS (CONTINUED) ......................... 8pt. Hel.
HEADINGS ................................ 8pt. Hel. Bold Oblique
SUB-HEADINGS ..................................... 6pt. Hel. Bold
BODY TEXT .................................................... 6pt. Hel.
TEXT – HORIZONTAL SCALING......<39 char. per inch
LEADING ............................................................. .05pt.
BULLETS ................................... 5pt. Square or Round
THICK RULES & BOUNDING BOX .................... 2.5pt.
THIN RULES ......................................................... .5pt.
A ON O S M E T C RE O N A ON O UM R E T C RE O N A ON O UM R E T C RE O N A O C N U ER A T C E O N T O C N U E H A H A E U D T N C N U E H A H A E
F U D T N
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O UM R E L C RE O N A ON O S M R E T C RE O N A ON O UM R E T C RE O N A ON N U ER A T C E O N TO C N U ER A T C E U D T N C N U E H A H A E F D T N C NS
FCH C
FCH FCH FC
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Reference ID: 4371429
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
PUSH THROUGH FOIL
Dist. by:
Foundation Consumer
Healthcare, LLC
Pittsburgh, PA 15205
LOT: 000000 EXP:00/00
1.5 mg levonorgestrel tablet
FONT SPECS
SOI .............. 6.05pt Ocean Sans MM – 512 SB 475 NO
DISTRIBUTED BY................... 7pt Ocean Sans Regular
Reference ID: 4371429
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
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:
t your regular birth control was used
incorrectly or failed
t you did not use any birth control
method
When not to use Plan B One-Step
®
.
Plan B One-Step
®
should not be used:
t as a regular birth control method,
because it’s not as effective as
regular birth control.
t if you are already pregnant,
because it will not work.
t if you are allergic to levonorgestrel
or any other ingredients in Plan B
One-Step
®
.
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
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 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?
t 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.
t if you have severe abdominal
pain, you may have an ectopic
pregnancy, and should get
immediate medical attention.
t 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.
t 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
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 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,
potato starch, talc
1-800-330-1271
www.PlanBOneStep.com
®
One One TTaablet. One Steblet. One Stepp..
Emergency Contraceptive
799-33-101010
©2017 Foundation Consumer Healthcare, LLC.
Rev. 12/2017 Printed in USA
®
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.
FPO
Data
Matrix
Reference ID: 4371429
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
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KAREN M MAHONEY
01/04/2019 10:41:49 AM
Signature Page 1 of 1
Reference ID: 4371429
(
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
