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Novel My Way Tabs Size: 12-1/8 x 13-1/2 Fold: 1-3/8 x 1-3/8 Type: 6 pt. Side A Rev 4/2012 Proof 5 6/11/2012 JB monohydrate, magnesium stearate, and talc. HIGHLIGHTS OF PRESCRIBING INFORMATION
My Way is not effective in terminating an existing pregnancy. (5.2) Effect on menses: My Way may alter the next expected menses. If menses is delayed beyond 1 Levonorgestrel has a molecular weight of 312.45, and the following structural and molecular These highlights do not include all the information needed to use My Way safely and effectively.
week, pregnancy should be considered. (5.3) See full prescribing information for My Way.
STI/HIV: My Way does not protect against STI/HIV. (5.4) My Way (levonorgestrel) tablet, 1.5 mg, for oral use
-------------------------------------------- ADVERSE REACTIONS ---------------------------------------------
Initial U.S. Approval: 1982
The most common adverse reactions (≥10%) in clinical trials included heavier menstrual bleeding(31%), nausea (14%), lower abdominal pain (13%), fatigue (13%), headache (10%), and dizziness --------------------------------------------INDICATIONS AND USAGE ------------------------------------------
My Way is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. My Way is available only by To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or
prescription for women younger than age 17 years, and available over the counter for women 17 www.fda.gov/medwatch
years and older. My Way is not intended for routine use as a contraceptive. (1) -------------------------------------------- DRUG INTERACTIONS--------------------------------------------
Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the ---------------------------------------- DOSAGE AND ADMINISTRATION -------------------------------------
One tablet taken orally as soon as possible within 72 hours after unprotected intercourse. Efficacy is effectiveness of progestin-only pills. (7) better if the tablet is taken as soon as possible after unprotected intercourse. (2) ----------------------------------------USE IN SPECIFIC POPULATIONS---------------------------------------
12 CLINICAL PHARMACOLOGY
Nursing Mothers: Small amounts of progestin pass into the breast milk of nursing women taking 12.1 Mechanism of Action
-------------------------------------- DOSAGE FORMS AND STRENGTHS -------------------------------------
Emergency contraceptive pills are not effective if a woman is already pregnant. My Way is believed to progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal --------------------------------------------- CONTRAINDICATIONS ---------------------------------------------
transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium).
My Way is not intended for use in premenarcheal (8.4) or postmenopausal females (8.5). It is not effective once the process of implantation has begun. See 17 for PATIENT COUNSELING INFORMATION
-------------------------------------- WARNINGS AND PRECAUTIONS ----------------------------------------
12.3 Pharmacokinetics
Ectopic pregnancy: Women who become pregnant or complain of lower abdominal pain after Revised: 08/2009
taking My Way should be evaluated for ectopic pregnancy. (5.1) Following a single dose administration of My Way in 30 women under fasting conditions, maximum plasma concentrations of levonorgestrel of 19.1 ng/mL were reached at 1.7 hours. See Table 2.
Table 2. Pharmacokinetic Parameter Values Following Single Dose Administration of FULL PRESCRIBING INFORMATION: CONTENTS*
My Way (levonorgestrel) tablet 1.5 mg to 30 Healthy Female Volunteers under Fasting Conditions 1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
9 DRUG ABUSE AND DEPENDENCE
4 CONTRAINDICATIONS
10 OVERDOSAGE
5 WARNINGS AND PRECAUTIONS
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
AUCt = area under the drug concentration curve from time 0 to time of last determinable 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility AUCinf = area under the drug concentration curve from time 0 to infinity 14 CLINICAL STUDIES
6 ADVERSE REACTIONS
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
7 DRUG INTERACTIONS
Effect of Food: The effect of food on the rate and the extent of levonorgestrel absorption following 8 USE IN SPECIFIC POPULATIONS
PRINCIPAL DISPLAY PANEL- TRADE CARTON
single oral administration of My Way has not been evaluated. * Sections or subsections omitted from the full prescribing information are not listed
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 FULL PRESCRIBING INFORMATION
6.2 Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Plan B (2 doses of 1 INDICATIONS AND USAGE
0.75 mg levonorgestrel taken 12 hours apart). Because these reactions are reported voluntarily from Following absorption, levonorgestrel is conjugated at the 17β-OH position to form sulfate conjugates My Way is a progestin-only emergency contraceptive indicated for prevention of pregnancy following a population of uncertain size, it is not always possible to reliably estimate their frequency or establish and, to a lesser extent, glucuronide conjugates in plasma. Significant amounts of conjugated and unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the unconjugated 3α, 5β-tetrahydrolevonorgestrel are also present in plasma, along with much smaller tablet should be taken as soon as possible within 72 hours of intercourse. amounts of 3α, 5α-tetrahydrolevonorgestrel and 16β hydroxylevonorgestrel. Levonorgestrel and its My Way is available only by prescription for women younger than age 17 years, and available over phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may byEdQ IEJ=sw9gdmzcAM0w54M2CD bM0Dx8By0QSjY 0ZQN3o6S4 0R4M1V7zLn ETM123 F0 the counter for women 17 years and older. My Way is not indicated for routine use as a contraceptive. differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users. General Disorders and Administration Site Conditions 2 DOSAGE AND ADMINISTRATION
Take My Way 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 About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted unprotected intercourse. My Way can be used at any time during the menstrual cycle. in feces, mostly as glucuronide conjugates. If vomiting occurs within two hours of taking the tablet, consideration should be given to repeating Specific Populations
Reproductive System and Breast Disorders Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain 3 DOSAGE FORMS AND STRENGTHS
This product is not intended for use in the premenarcheal population, and pharmacokinetic data are 7 DRUG INTERACTIONS
The My Way tablet is supplied as a white to off-white, round, flat tablets containing 1.5 mg of Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may levonorgestrel and debossed with “NL 620” on one side and plain on the other side. decrease the plasma concentrations of progestins, and may decrease the effectiveness of 4 CONTRAINDICATIONS
This product is not intended for use in postmenopausal women, and pharmacokinetic data are not progestin-only pills. Some drugs or herbal products that may decrease the effectiveness of My Way is contraindicated for use in the case of known or suspected pregnancy. 5 WARNINGS AND PRECAUTIONS
5.1 Ectopic Pregnancy
No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen (another form of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic. emergency contraception). There was a non-statistically significant increased rate of pregnancy among Chinese women in the My Way trial. The reason for this apparent increase in the pregnancy A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive rate with emergency contraceptives in Chinese women is unknown [see USE IN SPECIFIC 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 My Way. 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 My Way. No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of My 5.2 Existing Pregnancy
Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in My Way is not effective in terminating an existing pregnancy. some cases of co-administration with HIV protease inhibitors or with non-nucleoside reverse No formal studies were conducted to evaluate the effect of renal disease on the disposition of My 5.3 Effects on Menses
Some women may experience spotting a few days after taking My Way. Menstrual bleeding patterns Consult the labeling of all concurrently used drugs to obtain further information about interactions are often irregular among women using progestin-only oral contraceptives and women using with progestin-only pills or the potential for enzyme alterations. Drug-Drug Interactions
levonorgestrel for postcoital and emergency contraception. No formal drug-drug interaction studies were conducted with My Way [see DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS
If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of 8.1 Pregnancy
Many studies have found no harmful effects on fetal development associated with long-term use of 13 NONCLINICAL TOXICOLOGY
contraceptive doses of oral progestins. The few studies of infant growth and development that have 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
5.4 STI/HIV
been conducted with progestin-only pills have not demonstrated significant adverse effects. Carcinogenicity: There is no evidence of increased risk of cancer with short-term use of progestins.
My Way does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs). There was no increase in tumorgenicity following administration of levonorgestrel to rats for 2 years 8.3 Nursing Mothers
5.5 Physical Examination and Follow-up
mg/day, to dogs for 7 years at up to 0.125 mg/kg/day, or to rhesus monkeys for In general, no adverse effects of progestin-only pills have been found on breastfeeding performance A physical examination is not required prior to prescribing My Way. A follow-up physical or pelvic mg/kg/day. In another 7 year dog study, administration of levonorgestrel at 0.5 or on the health, growth, or development of the infant. However, isolated post-marketing cases of mg/kg/day did increase the number of mammary adenomas in treated dogs compared to controls.
examination is recommended if there is any doubt concerning the general health or pregnancy status 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 Genotoxicity: Levonorgestrel was not found to be mutagenic or genotoxic in the Ames Assay, in vitro 5.6 Fertility Following Discontinuation
mammalian culture assays utilizing mouse lymphoma cells and Chinese hamster ovary cells, and in an A rapid return of fertility is likely following treatment with My Way for emergency contraception; 8.4 Pediatric Use
therefore, routine contraception should be continued or initiated as soon as possible following use of Safety and efficacy of progestin-only pills for long-term contraception have been established in My Way to ensure ongoing prevention of pregnancy. women of reproductive age. Safety and efficacy are expected to be the same for postpubertal Fertility: There are no irreversible effects on fertility following cessation of exposures to levonorgestrel 6 ADVERSE REACTIONS
adolescents less than 17 years and for users 17 years and older. Use of My Way emergency 6.1 Clinical Trials Experience
contraception before menarche is not indicated. 14 CLINICAL STUDIES
Because clinical trials are conducted under widely varying conditions, adverse reaction rates 8.5 Geriatric Use
A double-blind, randomized, multicenter, multinational study evaluated and compared the efficacy observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of This product is not intended for use in postmenopausal women. and safety of three different regimens for emergency contraception. Subjects were enrolled at 15 sites another drug and may not reflect the rates observed in clinical practice. in 10 countries; the racial/ethnic characteristics of the study population overall were 54% Chinese, 34% Caucasian, and 12% Black or Asian (other than Chinese). 2,381 healthy women with a mean age My Way was studied in a randomized, double-blinded multicenter clinical trial. In this study, all No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher of 27 years, who needed emergency contraception within 72 hours of unprotected intercourse were women who had received at least one dose of study medication were included in the safety analysis: pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen (another form of involved and randomly allocated into one of the two levonorgestrel groups. A single dose of 1.5 mg 1,379 women in the My Way group, and 1,377 women in the Plan B group (2 doses of 0.75 mg emergency contraception). There was a non-statistically significant increased rate of pregnancy of levonorgestrel (My Way) was administered to women allocated into group 1. Two doses of 0.75 levonorgestrel taken 12 hours apart). The mean age of women given My Way was 27 years. The racial among Chinese women in the My Way trial. The reason for this apparent increase in the pregnancy mg levonorgestrel 12 hours apart (Plan B) were administered to women in group 2. In the My Way demographic of those enrolled was 54% Chinese, 12% Other Asian or Black, and 34% were rate with emergency contraceptives in Chinese women is unknown. group, 16 pregnancies occurred in 1,198 women and in the Plan B group, 20 pregnancies occurred Caucasian in each treatment group. 1.6% of women in the My Way group and 1.4% in Plan B group in 1,183 women. The number of pregnancies expected in each group was calculated based on the 8.7 Hepatic Impairment
timing of intercourse with regard to each woman’s menstrual cycle. Among women receiving My Way, No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of My The most common adverse events (>10%) in the clinical trial for women receiving My Way included 84% of expected pregnancies were prevented and among those women taking Plan B, 79% of heavier menstrual bleeding (30.9%), nausea (13.7%), lower abdominal pain (13.3%), fatigue expected pregnancies were prevented. The expected pregnancy rate of 8% (with no contraceptive (13.3%), and headache (10.3%). Table 1 lists those adverse events that were reported in > 4% of My 8.8 Renal Impairment
use) was reduced to approximately 1% with My Way. No formal studies were conducted to evaluate the effect of renal disease on the disposition of My Emergency contraceptives are not as effective as routine contraception since their failure rate, while low Table 1. Adverse Events in > 4% of Women, by % Frequency based on a single use, would accumulate over time with repeated use [see INDICATIONS AND USAGE 9 DRUG ABUSE AND DEPENDENCE
Most Common Adverse Events (MedDRA)
Levonorgestrel is not a controlled substance. There is no information about dependence associated N = 1359 (%)
In the clinical study, bleeding disturbances were the most common adverse event reported after taking the levonorgestrel-containing regimens. More than half of the women had menses within two 10 OVERDOSAGE
days of the expected time; however, 31% of women experienced change in their bleeding pattern There are no data on overdosage of My Way, although the common adverse event of nausea and during the study period; 4.5% of women had menses more than 7 days after the expected time.
16 HOW SUPPLIED/STORAGE AND HANDLING
11 DESCRIPTION
The My Way (Levonorgestrel) tablet , 1.5 mg is available in a PVC/aluminum foil blister package. The The My Way Tablet contains 1.5 mg of a single active steroid ingredient, levonorgestrel tablet is a white to off-white, round, flat, debossed with “NL 620” on one side and plain on the other [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, side containing 1.5 mg of levonorgestrel. progestogen. The inactive ingredients are colloidal silicon dioxide, pregelatinized starch, lactose Novel My Way Tabs Size: 12-1/8 x 13-1/2 Fold: 1-3/8 x 1-3/8 Type: 6 pt. Side B Rev 4/2012 Proof 5 6/11/2012 JB NDC 43386-620-30 (1 tablet unit of use package) How can I get the best results from My Way?
Store My Way at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. You have only a few days to try to prevent pregnancy after • If you vomit within 2 hours of taking the medication, call a 17 PATIENT COUNSELING INFORMATION
unprotected sex. The sooner you take My Way, the better it
healthcare professional to find out if you should repeat the dose. 17.1 Information for Patients
• Take My Way as soon as possible and not more than 72 hours after unprotected intercourse or a works. My Way should be taken as soon as possible within 72
Prescription only for women younger than age 17. If you are known or suspected contraceptive failure. hours (3 days) after unprotected sex.
younger than age 17, see a healthcare professional. • If you vomit within two hours of taking the tablet, immediately contact your healthcare provider to How effective is My Way?
What should I do if I have questions about My Way?
• Seek medical attention if you experience severe lower abdominal pain 3 to 5 weeks after taking My The sooner you take My Way, the better it will work. Take My If you have questions or need more information about this Way, in order to be evaluated for an ectopic pregnancy. Way as soon as possible after unprotected sex. If it is taken product, call 1-800-422-8689, visit our website at • After taking My Way, consider the possibility of pregnancy if your period is delayed more than one week beyond the date you expected your period. as soon as possible within 72 hours (3 days) after www.mywaypill.com, or ask a healthcare professional. • Do not use My Way as routine contraception. unprotected sex, it will significantly decrease the chance that Other information
• My Way is not effective in terminating an existing pregnancy. you will get pregnant. Seven out of every 8 women who • My Way does not protect against HIV-infection (AIDS) and other sexually transmitted Tablet is enclosed in a blister seal. Do not use if the blister
would have gotten pregnant will not become pregnant.
seal is broken.
• For women younger than age 17 years, My Way is available only by prescription. How will I know if My Way worked?
Store at room temperature 20–25°C (68–77°F). Most women will have their next menstrual period at the You may report side effects to FDA at 1-800-FDA-1088.
expected time or within a week of the expected time. If your Active ingredient: Levonorgestrel 1.5 mg
menstrual period is delayed beyond 1 week, you may be Inactive ingredients: colloidal silicon dioxide, pregelatinized
pregnant. You should get a pregnancy test and follow up with starch, magnesium stearate, talc, and lactose monohydrate What if I am already pregnant and use My Way?
Protect yourself in more ways than one!
Medication Guide
There is no medical evidence that My Way would harm a If you are sexually active, but you are not ready for a developing baby. If you take My Way (accidentally) after you pregnancy, it is important to use regular pregnancy are already pregnant or it does not work and you become protection. There are many types of birth control. Whichever pregnant, it is not likely to cause any harm to you or your type you choose, it is important to use your regular birth pregnancy. The pregnancy will continue. My Way will not control method as directed. This ensures that you have effective protection against pregnancy every time you have Birth Control and Sexually Transmitted Diseases What should I do if my menstrual period is delayed beyond
For additional information intended for healthcare 1 week and I have severe lower stomach (abdominal)
But things do not always go as planned. For example, if you professionals, please see enclosed Product Information for were using a condom and it broke or slipped, or if you did If you have severe lower stomach (abdominal) pain about 3 to not use your regular birth control as you should have, or if What is My Way?
5 weeks after taking My Way, you may have a pregnancy you did not use any birth control, My Way may work for you.
My Way is emergency contraception that helps prevent outside the uterus, which is called a tubal pregnancy. A tubal My Way is an emergency contraceptive that helps prevent pregnancy after birth control failure or unprotected sex. It is pregnancy requires immediate medical treatment, so you pregnancy after unprotected sex or when your birth control a backup method of preventing pregnancy and is not to be
should see a healthcare professional right away.
Can I use My Way for regular birth control?
Remember, My Way is only for emergency pregnancy My Way can reduce your chance of pregnancy after No. My Way should not be used for regular birth control. It prevention. There are many other products that work for unprotected sex (if your regular birth control was used is an emergency or backup method to be used if your regular regular birth control that are available by prescription or incorrectly or fails, or if you have had sex without birth birth control fails or is used incorrectly or if you have sex control). For example, if you were using a condom and it without birth control. You should protect yourself against There is also another form of protection to think about when broke or slipped, if you did not use your regular birth control STDs and pregnancy every time you have sex. If you have you have sex: protection against sexually transmitted as you should have, or if you did not use any birth control, unprotected sex again after taking My Way, it will not help diseases (STDs). Some common STDs are HIV/AIDS, chlamydia, genital herpes, gonorrhea, hepatitis, human What My Way is not.
How often can I use My Way?
papilloma virus (HPV), genital warts, syphilis, and My Way will not work if you are already pregnant and will not My Way is meant for emergency protection only, and is not trichomonas. Some of these STDs can be very serious and affect an existing pregnancy. My Way should not be used as designed to be used frequently. If you find that you need to can lead to infertility (inability to have a baby), problems regular birth control. It is important to have another reliable use emergency contraception often, talk to your healthcare during pregnancy, chronic illness, and even death.
source of birth control that is right for you. My Way will not professional and learn about methods of birth control and All sexually active women are at risk of catching STDs protect you from HIV infection (the virus that causes AIDS) STD prevention that are right for you.
because they may not know that their partner has an STD and other sexually transmitted diseases.
Will I experience any side effects from My Way?
(the partner himself may not know). If your partner uses a
When is the appropriate time to use My Way?
When used as directed, My Way is safe for women. Some latex condom correctly each and every time you have sex
You can use My Way after you have had unprotected sex in
women will have mild, temporary side effects, such as with him, this will help reduce, but not eliminate, the
the last 72 hours (3 days), and you do not want to become menstrual changes, nausea, lower stomach (abdominal) chance that you will catch an STD.
pain, tiredness, headache, dizziness, breast pain and No other birth control methods will effectively protect you My Way can be used as a backup or emergency method to vomiting. These are similar to the side effects that some from STDs. The female condom may give you some STD women have when taking regular birth control pills. Some protection, but it is not as effective as a male latex condom. • Your regular birth control method was used incorrectly or women taking My Way will have menstrual changes such as For more information on STDs, call the Centers for Disease failed (your partner’s condom broke or slipped) spotting or bleeding before their next period. Some women Control and Prevention (CDC) AIDS/STD Hotline. The CDC • You made a mistake with your regular method may have a heavier or lighter next period, or a period that is phone numbers are 1-800-342-AIDS (2437) for English, • You did not use any birth control method early or late. If your period is more than a week late, you
1-800-344-7432 for Spanish, or 1-800-243-7889 for hearing should get a pregnancy test.
When is it not appropriate to use My Way?
• My Way should not be used as a regular birth control What warnings should I know about when using My Way?
Be sure to protect yourself against pregnancy and STDs by method. It does not work as well as most other forms of My Way does not protect against AIDS virus (HIV) or other
using some form of birth control plus a latex condom. Of birth control when they are used consistently and correctly.
sexually transmitted diseases (STDs).
course, not having sex is the most effective way to prevent Do not use:
• If you are already pregnant (because it will not work) • My Way should not be used if you are already pregnant My Way is used to prevent pregnancy after unprotected sex.
• If you are allergic to levonogestrel or any of the ingredients My Way should not be used for regular birth control, if you
• My Way should not be used if you are allergic to are already pregnant (because it will not work), or if you
levonorgestrel or any other ingredients in My Way.
are allergic to levonorgestrel or any of the ingredients in
When using this product, you may have:
• My Way does not protect against HIV (the virus that causes AIDS) or other sexually transmitted diseases (STDs). The The sooner you take My Way, the better it will work.
best ways to protect yourself against getting HIV or other My Way does not protect against the AIDS virus (HIV) or
STDs are to use a latex condom correctly with every sexual other sexually transmitted diseases (STDs)
Common side effects associated with the use of My Way How does My Way work?
include menstrual changes, nausea, lower stomach My Way is one pill with levonorgestrel, a hormone that has (abdominal) pain, tiredness, headache, dizziness, breast pain been used in many birth control pills for over 35 years. My Way contains a higher dose of levonorgestrel than birth control pills, Keep out of reach of children.
but works in a similar way to prevent pregnancy. It works In case of overdose, get medical help or contact a Poison mainly by stopping the release of an egg from the ovary. It is Control Center right away at 1-800-222-1222. possible that My Way may also work by preventing fertilizationof an egg (the uniting of sperm with the egg) or by preventing What are the directions for using My Way?
attachment (implantation) to the uterus (womb).
Women 17 years of age and older:
• Take My Way as soon as possible within 72 hours (3 days)

Source: http://mywaypill.com/My_Way_PLR_format_insert.pdf