__________________ _________________
______________
______________ _____________
___________________ ___________________
______________ _______________
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Plan B
safely and effectively. See full prescribing information for Plan B.
Plan B (levonorgestrel) tablets, 0.75 mg, for oral use
Initial U.S. Approval: 1982
INDICATIONS AND USAGE
Plan B is a progestin-only emergency contraceptive, indicated for prevention
of pregnancy following unprotected intercourse or a known or suspected
contraceptive failure. Plan B is available only by prescription for women
younger than age 17 years, and available over the counter for women 17 years
and older. Plan B is not intended for routine use as a contraceptive. (1)
_______________
DOSAGE AND ADMINISTRATION
The first tablet is taken orally as soon as possible within 72 hours after
unprotected intercourse. The second tablet should be taken 12 hours after the
first dose. Efficacy is better if Plan B is taken as soon as possible after
unprotected intercourse. (2)
DOSAGE FORMS AND STRENGTHS
A total of two 0.75 mg tablets taken 12 hours apart as a single course of
treatment. (3)
CONTRAINDICATIONS
Known or suspected pregnancy. (4)
_______________
WARNINGS AND PRECAUTIONS
_______________
• Ectopic Pregnancy: Women who become pregnant or complain of
lower abdominal pain after taking Plan B
should be evaluated for
ectopic pregnancy. (5.1)
• Plan B is not effective in terminating an existing pregnancy. (5.2)
FULL PRESCRIBING INFORMATION: CONTENTS*
1
INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Ectopic Pregnancy
5.2 Existing Pregnancy
5.3 Effects on Menses
5.4 STI/HIV
5.5 Physical Examination and Follow-up
5.6 Fertility Following Discontinuation
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Race
8.7 Hepatic Impairment
8.8 Renal Impairment
9 DRUG ABUSE AND DEPENDENCE
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Information for Patients
• Effect on menses: Plan B may alter the next expected menses. If
menses is delayed beyond 1 week, pregnancy should be
considered. (5.3)
• STI/HIV: Plan B does not protect against STI/HIV. (5.4)
___________________
ADVERSE REACTIONS
___________________
The most common adverse reactions (≥ 10%) in the clinical trial included
menstrual changes (26%), nausea (23%), abdominal pain (18%), fatigue
(17%), headache (17%), dizziness (11%) and breast tenderness (11%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Teva
Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
___________________
DRUG INTERACTIONS
____________________
Drugs or herbal products that induce certain enzymes, such as CYP3A4, may
decrease the effectiveness of progestin-only pills. (7)
USE IN SPECIFIC POPULATIONS
• Nursing Mothers: Small amounts of progestin pass into the breast
milk of nursing women taking progestin-only pills for long-term
contraception, resulting in detectable steroid levels in infant
plasma. (8.3)
• Plan B is not intended for use in pediatric (premenarcheal) (8.4) or
postmenopausal women (8.5).
• Clinical trials demonstrated a higher pregnancy rate in the Chinese
population. (8.6)
See 17 for PATIENT COUNSELING INFORMATION
Revised: 9/2017
*Sections or subsections omitted from the full prescribing information are not listed.
1
Reference ID: 4160300
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Plan B
®
is a progestin-only emergency contraceptive indicated for prevention of pregnancy
following unprotected intercourse or a known or suspected contraceptive failure. To obtain
optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of
intercourse. The second tablet should be taken 12 hours later.
Plan B is available only by prescription for women younger than age 17 years, and available over
the counter for women 17 years and older.
Plan B is not indicated for routine use as a contraceptive.
2 DOSAGE AND ADMINISTRATION
Take one tablet of Plan B orally as soon as possible within 72 hours after unprotected intercourse
or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon as
possible after unprotected intercourse. The second tablet should be taken 12 hours after the first
dose. Plan B can be used at any time during the menstrual cycle.
If vomiting occurs within two hours of taking either dose of medication, consideration should be
given to repeating the dose.
3 DOSAGE FORMS AND STRENGTHS
Each Plan B tablet is supplied as a white, round tablet containing 0.75 mg of levonorgestrel and
is marked with INOR on one side.
4 CONTRAINDICATIONS
Plan B is contraindicated for use in the case of known or suspected pregnancy.
5 WARNINGS AND PRECAUTIONS
5.1 Ectopic Pregnancy
Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of
pregnancies reported in clinical studies of routine use of progestin-only contraceptives are
ectopic.
A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive
method. Healthcare providers, however, should consider the possibility of an ectopic pregnancy
in women who become pregnant or complain of lower abdominal pain after taking Plan B. A
follow-up physical or pelvic examination is recommended if there is any doubt concerning the
general health or pregnancy status of any woman after taking Plan B.
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5.2 Existing Pregnancy
Plan B is not effective in terminating an existing pregnancy.
5.3 Effects on Menses
Some women may experience spotting a few days after taking Plan B. Menstrual bleeding
patterns are often irregular among women using progestin-only oral contraceptives and women
using levonorgestrel for postcoital and emergency contraception.
If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of
pregnancy.
5.4 STI/HIV
Plan B does not protect against HIV infection (AIDS) or other sexually transmitted infections
(STIs).
5.5 Physical Examination and Follow-up
A physical examination is not required prior to prescribing Plan B. A follow-up physical or
pelvic examination is recommended if there is any doubt concerning the general health or
pregnancy status of any woman after taking Plan B.
5.6 Fertility Following Discontinuation
A rapid return of fertility is likely following treatment with Plan B for emergency contraception;
therefore, routine contraception should be continued or initiated as soon as possible following
use of Plan B to ensure ongoing prevention of pregnancy.
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates
observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials
of another drug and may not reflect the rates observed in clinical practice.
A double-blind, controlled clinical trial in 1,955 evaluable women compared the efficacy and
safety of Plan B (one 0.75 mg tablet of levonorgestrel taken within 72 hours of unprotected
intercourse, and one tablet taken 12 hours later) to the Yuzpe regimen (two tablets each
containing 0.25 mg levonorgestrel and 0.05 mg ethinyl estradiol, taken within 72 hours of
intercourse, and two tablets taken 12 hours later).
The most common adverse events (>10%) in the clinical trial for women receiving Plan B
included menstrual changes (26%), nausea (23%), abdominal pain (18%), fatigue (17%),
headache (17%), dizziness (11%), and breast tenderness (11%). Table 1 lists those adverse
events that were reported in ≥ 5% of Plan B users.
3
Reference ID: 4160300
Table 1: Adverse Events in ≥5% of Women, by % Frequency
Plan B
Levonorgestrel
N=977 (%)
Nausea 23.1
Abdominal Pain 17.6
Fatigue 16.9
Headache 16.8
Heavier Menstrual Bleeding 13.8
Lighter Menstrual Bleeding 12.5
Dizziness 11.2
Breast Tenderness 10.7
Vomiting 5.6
Diarrhea 5.0
6.2 Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Plan B.
Because these reactions are reported voluntarily from a population of uncertain size, it is not
always possible to reliably estimate their frequency or establish a causal relationship to drug
exposure.
Gastrointestinal Disorders
Abdominal Pain, Nausea, Vomiting
General Disorders and Administration Site Conditions
Fatigue
Nervous System Disorders
Dizziness, Headache
Reproductive System and Breast Disorders
Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain
7 DRUG INTERACTIONS
Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins
may decrease the plasma concentrations of progestins, and may decrease the effectiveness of
progestin-only pills. Some drugs or herbal products that may decrease the effectiveness of
progestin-only pills include:
• barbiturates (including primidone)
• bosentan
4
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• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John’s wort
• topiramate
Significant changes (increase or decrease) in the plasma levels of the progestin have been noted
in some cases of co-administration with HIV protease inhibitors or with non-nucleoside reverse
transcriptase inhibitors. Concomitant administration of efavirenz has been found to reduce
plasma levels of levonorgestrel (AUC) by around 50%, which may reduce the effectiveness of
Plan B.
Consult the labeling of all concurrently used drugs to obtain further information about
interactions with progestin-only pills or the potential for enzyme alterations.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Many studies have found no harmful effects on fetal development associated with long-term use
of contraceptive doses of oral progestins. The few studies of infant growth and development that
have been conducted with progestin-only pills have not demonstrated significant adverse effects.
8.3 Nursing Mothers
In general, no adverse effects of progestin-only pills have been found on breastfeeding
performance or on the health, growth or development of the infant. However, isolated post-
marketing cases of decreased milk production have been reported. Small amounts of progestins
pass into the breast milk of nursing mothers taking progestin-only pills for long-term
contraception, resulting in detectable steroid levels in infant plasma.
8.4 Pediatric Use
Safety and efficacy of progestin-only pills for long-term contraception have been established in
women of reproductive age. Safety and efficacy are expected to be the same for postpubertal
adolescents under the age of 16 and for users 16 years and older. Use of Plan B emergency
contraception before menarche is not indicated.
8.5 Geriatric Use
This product is not intended for use in postmenopausal women.
5
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8.6 Race
No formal studies have evaluated the effect of race. However, clinical trials demonstrated a
higher pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen (another form
of emergency contraception). The reason for this apparent increase in the pregnancy rate with
emergency contraceptives in Chinese women is unknown.
8.7 Hepatic Impairment
No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of
Plan B.
8.8 Renal Impairment
No formal studies were conducted to evaluate the effect of renal disease on the disposition of
Plan B.
9 DRUG ABUSE AND DEPENDENCE
Levonorgestrel is not a controlled substance. There is no information about dependence
associated with the use of Plan B.
10 OVERDOSAGE
There are no data on overdosage of Plan B, although the common adverse event of nausea and
associated vomiting may be anticipated.
11 DESCRIPTION
Each Plan B tablet contains 0.75 mg of a single active steroid ingredient, levonorgestrel [18,19-
Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17α)-(-)-], a totally synthetic progestogen.
The inactive ingredients present are colloidal silicon dioxide, potato starch, gelatin, magnesium
stearate, talc, corn starch, and lactose monohydrate. Levonorgestrel has a molecular weight of
312.45, and the following structural and molecular formulas:
6
Reference ID: 4160300
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Emergency contraceptive pills are not effective if a woman is already pregnant. Plan B is
believed to act as an emergency contraceptive principally by preventing ovulation or fertilization
(by altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by
altering the endometrium). It is not effective once the process of implantation has begun.
12.3 Pharmacokinetics
Absorption
No specific investigation of the absolute bioavailability of Plan B in humans has been conducted.
However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral
administration (bioavailability about 100%) and is not subject to first pass metabolism.
After a single dose of Plan B (0.75 mg) administered to 16 women under fasting conditions,
maximum serum concentrations of levonorgestrel were 14.1 + 7.7 ng/mL (mean + SD) at an
average of 1.6 + 0.7 hours.
Table 2: Pharmacokinetic Parameter Values Following Single Dose Administration of
Plan B (Levonorgestrel) Tablets 0.75 mg to Healthy Female Volunteers
under Fasting Conditions
Mean (± SD)
C
max
(ng/mL)
T
max
(h)
CL
(L/h)
V
d
(L)
t
½
(h)
AUC
inf
(ng/mL.h)
Levonorgestrel 14.1 (7.7) 1.6 (0.7) 7.7 (2.7) 260.0 24.4 (5.3) 123.1 (50.1)
C
max
= maximum concentration
T
max
= time to maximum concentration
CL = clearance
V
d
= volume of distribution
t
1/2
= elimination half life
AUC
inf
= area under the drug concentration curve from time 0 to infinity
Effect of Food: The effect of food on the rate and the extent of levonorgestrel absorption
following single oral administration of Plan B has not been evaluated.
Distribution
The apparent volume of distribution of levonorgestrel is reported to be approximately 1.8 L/kg. It
is about 97.5 to 99% protein-bound, principally to sex hormone binding globulin (SHBG) and, to
a lesser extent, serum albumin.
Metabolism
Following absorption, levonorgestrel is conjugated at the 17β-OH position to form sulfate
conjugates and, to a lesser extent, glucuronide conjugates in plasma. Significant amounts of
7
Reference ID: 4160300
conjugated and unconjugated 3α, 5β-tetrahydrolevonorgestrel are also present in plasma, along
with much smaller amounts of 3α, 5α-tetrahydrolevonorgestrel and 16βhydroxylevonorgestrel.
Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates.
Metabolic clearance rates may differ among individuals by several-fold, and this may account in
part for the wide variation observed in levonorgestrel concentrations among users.
Excretion
About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are
excreted in feces, mostly as glucuronide conjugates.
Specific Populations
Pediatric: This product is not intended for use in the pediatric (pre-menarcheal) population, and
pharmacokinetic data are not available for this population.
Geriatric: This product is not intended for use in postmenopausal women and pharmacokinetic
data are not available for this population.
Race: No formal studies have evaluated the effect of race on pharmacokinetics of Plan B.
However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both Plan
B and the Yuzpe regimen (another form of emergency contraception). The reason for this
apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is
unknown [see USE IN SPECIFIC POPULATIONS (8.6)].
Hepatic Impairment: No formal studies were conducted to evaluate the effect of hepatic disease
on the disposition of Plan B.
Renal Impairment: No formal studies were conducted to evaluate the effect of renal disease on
the disposition of Plan B.
Drug-Drug Interactions
No formal drug-drug interaction studies were conducted with Plan B [see DRUG
INTERACTIONS (7)].
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity: There is no evidence of increased risk of cancer with short-term use of
progestins. There was no increase in tumorgenicity following administration of levonorgestrel to
rats for 2 years at approximately 5 µg/day, to dogs for 7 years at up to 0.125 mg/kg/day, or to
rhesus monkeys for 10 years at up to 250 µg/kg/day. In another 7 year dog study, administration
of levonorgestrel at 0.5 mg/kg/day did increase the number of mammary adenomas in treated
dogs compared to controls. There were no malignancies.
Genotoxicity: Levonorgestrel was not found to be mutagenic or genotoxic in the Ames Assay, in
vitro mammalian culture assays utilizing mouse lymphoma cells and Chinese hamster ovary
cells, and in an in vivo micronucleus assay in mice.
8
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Fertility: There are no irreversible effects on fertility following cessation of exposures to
levonorgestrel or progestins in general.
14 CLINICAL STUDIES
A double-blind, randomized, multinational controlled clinical trial in 1,955 evaluable women
(mean age 27) compared the efficacy and safety of Plan B (one 0.75 mg tablet of levonorgestrel
taken within 72 hours of unprotected intercourse, and one tablet taken 12 hours later) to the
Yuzpe regimen (two tablets each containing 0.25 mg levonorgestrel and 0.05 mg ethinyl
estradiol, taken within 72 hours of intercourse, and two additional tablets taken 12 hours later).
After a single act of intercourse occurring anytime during the menstrual cycle, the expected
pregnancy rate of 8% (with no contraceptive use) was reduced to approximately 1% with Plan B.
Emergency contraceptives are not as effective as routine hormonal contraception since their
failure rate, while low based on a single use, would accumulate over time with repeated use [see
INDICATIONS AND USAGE (1)].
At the time of expected menses, approximately 74% of women using Plan B had vaginal
bleeding similar to their normal menses, 14% bled more than usual, and 12% bled less than
usual. The majority of women (87%) had their next menstrual period at the expected time or
within + 7 days, while 13% had a delay of more than 7 days beyond the anticipated onset of
menses.
16 HOW SUPPLIED/STORAGE AND HANDLING
Plan B (levonorgestrel) tablets, 0.75 mg, are available for a single course of treatment in
PVC/aluminum foil blister packages of two tablets each. The tablet is white, round and marked
INOR on one side.
Available as: Unit-of-use NDC 51285-769-93
Store Plan B tablets at controlled room temperature, 20° to 25°C (68° to 77°F); excursions
permitted between 15° to 30°C (59° to 86°F) [see USP].
17 PATIENT COUNSELING INFORMATION
17.1 Information for Patients
• Take Plan B as soon as possible and not more than 72 hours after unprotected
intercourse or a known or suspected contraceptive failure.
• If you vomit within two hours of taking either tablet, immediately contact your
healthcare provider to discuss whether to take another tablet.
• Seek medical attention if you experience severe lower abdominal pain 3 to 5 weeks
after taking Plan B, in order to be evaluated for an ectopic pregnancy.
• After taking Plan B, consider the possibility of pregnancy if your period is delayed
more than one week beyond the date you expected your period.
9
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• Do not use Plan B as routine contraception.
• Plan B is not effective in terminating an existing pregnancy.
• Plan B does not protect against HIV-infection (AIDS) and other sexually transmitted
diseases/infections.
• For women younger than age 17 years, Plan B is available only by prescription.
Mfg. by Gedeon Richter, Ltd., Budapest, Hungary
for Teva Women’s Health, Inc.
Subsidiary of Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
PLA-001
Rev. 9/2017
10
Reference ID: 4160300
Plan B
®
Emergency Contraceptive.
Because the unexpected happens.
Important Information About Plan B
®
, Birth Control & Sexually Transmitted
Diseases
For additional information intended for healthcare professionals, please see
enclosed Product Information for Plan B
®
.
Plan B
®
logo
Emergency Contraceptive
From the makers of Plan B
®
, Teva Women’s Health, Inc., a subsidiary of Teva
Pharmaceuticals USA, Inc.
What is Plan B
®
?
Plan B
®
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
®
is not.
Plan B
®
will not work if you are already pregnant and will not affect an existing
pregnancy. Plan B
®
will not protect you from HIV infection (the virus that causes
AIDS) and other sexually transmitted diseases (STDs).
When should I use Plan B
®
?
The sooner you take emergency contraception, the better it works. You should use
Plan B
®
within 72 hours (3 days) after you have had unprotected sex.
Plan B
®
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
®
?
Plan B
®
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.
Reference ID: 4160300
• if you are allergic to levonorgestrel or any other ingredients in Plan B
®
.
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
®
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
®
work?
Plan B
®
is two tablets with levonorgestrel, a hormone that has been used in many
birth control pills for several decades. Plan B
®
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
®
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
®
?
You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or
unprotected sex. The sooner you take Plan B
®
, the better it works. Take the
first Plan B
®
tablet as soon as possible within 72 hours (3 days) after
unprotected sex. Take the second tablet 12 hours later.
How effective is Plan B
®
?
If Plan B
®
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
®
worked?
You will know Plan B
®
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
®
is safe and effective. Side effects may include
changes in your period, nausea, lower stomach (abdominal) pain, tiredness,
Reference ID: 4160300
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 are the directions for using Plan B
®
?
Women 17 years of age and older:
• Take the first Plan B
®
tablet as soon as possible within 72 hours (3 days) after
unprotected sex.
• Take the second tablet 12 hours after you take the first tablet.
• If you vomit within 2 hours of taking either dose of medication, call a healthcare
professional to find out if you should repeat that dose.
Prescription only for women younger than age 17. If you are younger than 17, see
a healthcare professional.
What if I still have questions about Plan B
®
?
If you have questions or need more information, call our toll-free number, 1-800-
330-1271 or ask a healthcare professional.
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 open.
Store at room temperature 20–25°C (68–77°F).
You may report side effects to FDA at 1-800-FDA-1088.
Active ingredient: levonorgestrel 0.75 mg in each tablet
Inactive ingredients: colloidal silicon dioxide, potato starch, gelatin, magnesium
stearate, talc, corn starch, lactose monohydrate
1-800-330-1271
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.
Reference ID: 4160300
Manufacturer logo lock up Plan B logo lock up
Mfg. by Gedeon Richter, Ltd., Budapest, Hungary
for Teva Women’s Health, Inc.
Subsidiary of Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
©2017 Teva Women’s Health, Inc.
September 2017 Printed in USA
Reference ID: 4160300
