Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

21 white LO/OVRAL tablets, each containing 0.3 mg of norgestrel ( dl  -13-beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon- 4-en-3-one), a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol (19-nor-17(alpha)-pregna-1,3,5(10)-trien-20- yne-3,17-diol), and 7 pink inert tablets. The inactive ingredients present are cellulose, D&C Red 30, lactose, magnesium stearate, and polacrilin potassium.

See LO/OVRAL®.

See LO/OVRAL.

CONTRAINDICATIONS

See LO/OVRAL.

See LO/OVRAL.

PRECAUTIONS

See LO/OVRAL.

Drug Interactions:   See LO/OVRAL.

Carcinogenesis:   See LO/OVRAL.

Pregnancy:   See LO/OVRAL.

Nursing Mothers:   See LO/OVRAL.

Information for the Patient: See LO/OVRAL.

ADVERSE REACTIONS

See LO/OVRAL.

OVERDOSAGE

See LO/OVRAL.

NONCONTRACEPTIVE HEALTH BENEFITS

See LO/OVRAL.

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, LO/OVRAL-28 must be taken exactly as directed and at intervals not exceeding 24 hours.

The dosage of LO/OVRAL-28 is one white tablet daily for 21 consecutive days, followed by one pink inert tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that tablets be taken at the same time each day, preferably after the evening meal or at bedtime.

During the first cycle of medication, the patient is instructed to begin taking LO/OVRAL-28 on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 21 consecutive days followed by one pink inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets. During the first cycle, contraceptive reliance should not be placed on LO/OVRAL-28 until a white tablet has been taken daily for 7 consecutive days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days on white tablets--7 days on pink inert tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself by using another method of birth control until she has taken a white tablet daily for 7 consecutive days.

If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician. Although the occurrence of pregnancy is highly unlikely if LO/OVRAL-28 is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.

For additional patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the DETAILED PATIENT LABELING for LO/OVRAL.

Any time the patient misses two or more white tablets, she should also use another method of contraception until she has taken a white tablet daily for seven consecutive days. If the patient misses one or more pink tablets, she is still protected against pregnancy provided she begins taking white tablets again on the proper day.

If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. While there is little likelihood of ovulation occurring if only one or two white tablets are missed, the possibility of ovulation increases with each successive day that scheduled white tablets are missed.

In the nonlactating mother, LO/OVRAL-28 may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see " Contraindications ," " ," and " Precautions " concerning thromboembolic disease). It is to be noted that early resumption of ovulation may occur if Parlodel® (bromocriptine mesylate) has been used for the prevention of lactation.

HOW SUPPLIED

LO/OVRAL®-28 Tablets (0.3 mg norgestrel and 0.03 mg ethinyl estradiol) are available in packages of 6 PILPAK® dispensers, each containing 28 tablets as follows:

21 active tablets, NDC 0008-0078, white, round tablet marked "WYETH" and "78".

7 inert tablets, NDC 0008-0486, pink, round tablet marked "WYETH" and "486".

ALSO AVAILABLE:

LO/OVRAL®-28 Tablets (0.3 mg norgestrel and 0.03 mg ethinyl estradiol) are available in packages of 12 PILPAK® dispensers for clinic use only, each containing 28 tablets as follows:

21 active tablets, NDC 0008-0078, white, round tablet marked "WYETH" and "78".

7 inert tablets, NDC 0008-0486, pink, round tablet marked "WYETH" and "486".

Store at room temperature, approx. 25°C (77°F).

PRODUCT PHOTO(S):

References available upon request.

Brief Summary Patient Package Insert: See LO/OVRAL.

DETAILED PATIENT LABELING:   See LO/OVRAL.

HOW TO TAKE THE PILL

For Lo/Ovral-28 PILPAK® Dispenser, See LO/OVRAL.

For Lo/Ovral-28 Clinic Pilpak®, See below.

HOW TO TAKE THE PILL

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

IMPORTANT POINTS TO REMEMBER

BEFORE YOU START TAKING YOUR PILLS:

1. BE SURE TO READ THESE DIRECTIONS:
   Before you start taking your pills.
   Anytime you are not sure what to do.
2. THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME TIME.
   If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
3. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1-3 PACKS OF PILLS.
   If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your doctor or clinic.
4. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills.
   On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
5. IF YOU HAVE VOMITING OR DIARRHEA, for any reason, or IF YOU TAKE SOME MEDICINES, including some antibiotics, your pills may not work as well. Use a back-up method (such as condoms or foam) until you check with your doctor or clinic.
6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or clinic about how to make pill-taking easier or about using another method of birth control.
7. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your doctor or clinic.

NORDETTE®-21, OVRAL®, LO/OVRAL®, NORDETTE®-28, OVRAL®-28, AND LO/OVRAL®-28

BEFORE YOU START TAKING YOUR PILLS

1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL.
   It is important to take it at about the same time every day.
2. LOOK AT YOUR PILL PACK TO SEE IF IT HAS 21 OR 28 PILLS:
   The 21-pill pack has 21 "active" white or light-orange pills (with hormones) to take for 3 weeks, followed by 1 week without pills.
   The 28-pill pack has 21 "active" white or light-orange pills (with hormones) to take for 3 weeks, followed by 1 week of reminder pink pills (without hormones).
3. ALSO FIND:
   
   1. where on the pack to start taking pills,
   2. in what order to take the pills (follow the arrows), and
   3. the week numbers as shown in the picture below.
      
4. BE SURE YOU HAVE READY AT ALL TIMES:
   ANOTHER KIND OF BIRTH CONTROL (such as condoms or foam) to use as a back-up in case you miss pills.
   AN EXTRA, FULL PILL PACK.

WHEN TO START THE FIRST PACK OF PILLS:

For the 21-day pill pack you have two choices of which day to start taking your first pack of pills. (See DAY 1 START or SUNDAY START directions below.) Decide with your doctor or clinic which is the best day for you. The 28-day pill pack accommodates a SUNDAY START only. For either pill pack pick a time of day which will be easy to remember.

DAY 1 START:

These instructions are for the 21-day pill pack only. The 28-day pill pack does not accommodate a DAY 1 START dosage regimen.

1. Take the first "active" white or light-orange pill of the first pack during the first 24 hours of your period.
2. You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period.

SUNDAY START:

These instructions are for either the 21-day or the 28-day pill pack.

1. Take the first "active" white or light-orange pill of the first pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day.
2. Use another method of birth control as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). Condoms or foam are good back-up methods of birth control.

WHAT TO DO DURING THE MONTH:

1. TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY.
   Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea).
   Do not skip pills even if you do not have sex very often.
2. WHEN YOU FINISH A PACK OR SWITCH YOUR BRAND OF PILLS:
   21 pills:   Wait 7 days to start the next pack. You will probably have your period during that week. Be sure that no more than 7 days pass between 21-day packs.
   28 pills:   Start the next pack on the day after your last "reminder" pill. Do not wait any days between packs.

WHAT TO DO IF YOU MISS PILLS

If you MISS 1 white or light-orange "active" pill:

1. Take it as soon as you remember. Take the next pill at your regular time. This means you take 2 pills in 1 day.
2. You do not need to use a back-up birth control method if you have sex.

If you MISS 2 white or light-orange "active" pills in a row in WEEK 1 OR WEEK 2 of your pack:

1. Take 2 pills on the day you remember and 2 pills the next day.
2. Then take 1 pill a day until you finish the pack.
3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or foam) as a back-up for those 7 days.

If you MISS 2 white or light-orange "active" pills in a row in THE 3rd WEEK:

The Day 1 Starter instructions are for the 21-day pill pack only. The 28-day pill pack does not accommodate a DAY 1 START dosage regimen. The Sunday Starter instructions are for either the 21-day or 28-day pill pack.

1. If you are a Day 1 Starter:
   THROW OUT the rest of the pill pack and start a new pack that same day.
   If you are a Sunday Starter:
   Keep taking 1 pill every day until Sunday.
   On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day.
2. You may not have your period this month but this is expected.
   However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant.
3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or foam) as a back-up for those 7 days.

If you MISS 3 OR MORE white or light-orange "active" pills in a row (during the first 3 weeks):

The Day 1 Starter instructions are for the 21-day pill pack only. The 28-day pill pack does not accommodate a DAY 1 START dosage regimen. The Sunday Starter instructions are for either the 21-day or 28-day pill pack.

1. If you are a Day 1 Starter:
   THROW OUT the rest of the pill pack and start a new pack that same day.
   If you are a Sunday Starter:
   Keep taking 1 pill every day until Sunday.
   On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day.
2. You may not have your period this month but this is expected.
   However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant.
3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or foam) as a back-up for those 7 days.

A REMINDER FOR THOSE ON 28-DAY PACKS:

If your forget any of the 7 pink "reminder" pills in Week 4:

THROW AWAY the pills you missed.

Keep taking 1 pill each day until the pack is empty.

You do not need a back-up method if you start your next pack on time.

FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED:

Use a BACK-UP METHOD anytime you have sex.

KEEP TAKING ONE PILL EACH DAY until you can reach your doctor or clinic.

OVRETTE®

Ovrette is administered on a continuous daily dosage schedule, one tablet each day, every day of the year. Take the first tablet on the first day of your menstrual period. Tablets should be taken at the same time every day without interruption, whether bleeding occurs or not. If bleeding is prolonged (more than 8 days) or unusually heavy, you should contact your doctor.

Forgotten pills

The risk of pregnancy increases with each tablet missed. Therefore, it is very important that you take one tablet daily as directed. If you miss one tablet, take it as soon as you remember and also take your next tablet at the regular time. If you miss two tablets, take one of the missed tablets as soon as you remember, as well as your regular tablet for that day at the proper time. Furthermore, you should use another method of birth control in addition to taking Ovrette until you have taken fourteen days (2 weeks) of medication.

If more than two tablets have been missed, Ovrette should be discontinued immediately and another method of birth control used until the start of your next menstrual period. Then you may resume taking Ovrette.

Pregnancy due to pill failure

The incidence of pill failure resulting in pregnancy is approximately less than 1.0% if taken every day as directed, but more typical failure rates are less than 3.0%. If failure does occur, the risk to the fetus is minimal.

RISKS TO THE FETUS

If you do become pregnant while using oral contraceptives, the risk to the fetus is small, on the order of no more than one per thousand. You should, however, discuss the risks to the developing child with your doctor.

Pregnancy after stopping the pill

There may be some delay in becoming pregnant after you stop using oral contraceptives, especially if you had irregular menstrual cycles before you used oral contraceptives. It may be advisable to postpone conception until you begin menstruating regularly once you have stopped taking the pill and desire pregnancy.

There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping the pill.

Overdosage

Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your health-care provider or pharmacist.

Other information

Your health-care provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the health-care provider believes that it is appropriate to postpone it. You should be reexamined at least once a year. Be sure to inform your health-care provider if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your health-care provider, because this is a time to determine if there are early signs of side effects of oral-contraceptive use.

Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth-control pills.

HEALTH BENEFITS FROM ORAL CONTRACEPTIVES: See LO/OVRAL.

Manufactured by:

Wyeth Laboratories

A Wyeth-Ayerst Company

Philadelphia, PA 19101

CI 4259-3  Revised August 14, 1996