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Ortho-Novum

[Norethindrone/Ethinyl Estradiol]

2) in what order to take the pills.

4. BE SURE YOU HAVE READY AT ALL TIMES: ANOTHER KIND OF BIRTH CONTROL (such as condoms or spermicide) to use as a back-up method in case you miss pills. AN EXTRA, FULL PILL PACK.


WHEN TO START THE FIRST PACK OF PILLS

Text Continues Below



You have a choice of which day to start taking your first pack of pills. ORTHO-NOVUM 7/ 7/ 7, ORTHO-NOVUM 10/ 11, ORTHO-NOVUM 1/ 35, and MODICON are available in the DIALPAK ® Tablet Dispenser which is pre-set
for a Sunday Start. Day 1 Start is also provided. Decide with your healthcare provider which is the best day for you. Pick a time of day which will be easy to remember.

SUNDAY START:
ORTHO-NOVUM 7/ 7/ 7: Take the first "active" white 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 the same day.


ORTHO-NOVUM 10/ 11: Take the first "active" white 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 the same day.
ORTHO-NOVUM 1/ 35: Take the first "active" peach 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 the same day.
MODICON: Take the first "active" white 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 the same day.

Use another method of birth control such as condoms or spermicide as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days).
DAY 1 START:

ORTHO-NOVUM 7/ 7/ 7: Take the first "active" white pill of the first pack during the first 24 hours of your period.
ORTHO-NOVUM 10/ 11: Take the first "active" white pill of the first pack during the first 24 hours of your period.
ORTHO-NOVUM 1/ 35: Take the first "active" peach pill of the first pack during the first 24 hours of your period.
MODICON: Take the first "active" white pill of the first pack during the first 24 hours of your period.

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.


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: 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
ORTHO-NOVUM 7/ 7/ 7:
If you MISS 1 white, light peach, or peach "active" pill:
1. Take it as soon as you remember. Take the next pill at your regular time. This means you may 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 peach "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 COULD 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 spermicide) as a back-up method for those 7 days.

If you MISS 2 peach "active" pills in a row in THE 3RD WEEK:
1a. 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.

1b. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack 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 healthcare provider because you might be pregnant.

3. You COULD 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 spermicide) as a back-up method for those 7 days.
If you MISS 3 OR MORE white, light peach, or peach "active" pills in a row (during the first 3 weeks):

1a. 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.
1b. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack 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 healthcare provider because you might be pregnant.

3. You COULD 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 spermicide) as a back-up method for those 7 days.
ORTHO-NOVUM 10/ 11:
If you MISS 1 white or peach "active" pill:
1. Take it as soon as you remember. Take the next pill at your regular time. This means you may 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 peach "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 COULD 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 spermicide) as a back-up method for those 7 days.


If you MISS 2 peach "active" pills in a row in THE 3RD WEEK:
1a. 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.

1b. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack 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 healthcare provider because you might be pregnant.

3. You COULD 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 spermicide) as a back-up method for those 7 days.

If you MISS 3 OR MORE white or peach "active" pills in a row (during the first 3 weeks):
1a. 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.

1b. If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start a new pack 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 healthcare provider because you might be pregnant.

3. You COULD 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 spermicide) as a back-up method for those 7 days.

ORTHO-NOVUM 1/ 35:
If you MISS 1 peach "active" pill:
1. Take it as soon as you remember. Take the next pill at your regular time. This means you may 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 peach "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 COULD 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 spermicide) as a back-up method for those 7 days.

If you MISS 2 peach "active" pills in a row in THE 3RD WEEK:
1a. 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.


1b. If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start a new pack 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 healthcare provider because you might be pregnant.

3. You COULD 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 spermicide) as a back-up method for those 7 days.

If you MISS 3 OR MORE peach "active" pills in a row (during the first 3 weeks):
1a. 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.

1b. If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start a new pack 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 healthcare provider because you might be pregnant.

3. You COULD 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 spermicide) as a back-up method for those 7 days.

MODICON:

If you MISS 1 white "active" pill:
1. Take it as soon as you remember. Take the next pill at your regular time. This means you may 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 "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 COULD 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 spermicide) as a back-up method for those 7 days.

If you MISS 2 white "active" pills in a row in THE 3RD WEEK:
1a. 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.

1b. If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start a new pack 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 healthcare provider because you might be pregnant.

3. You COULD 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 spermicide) as a back-up method for those 7 days.

If you MISS 3 OR MORE white "active" pills in a row (during the first 3 weeks):
1a. 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.

1b. If you are a Day 1 Starter:
THROW OUT the rest of the pill pack and start a new pack 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 healthcare provider because you might be pregnant.

3. You COULD 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 spermicide) as a back-up method for those 7 days.

A REMINDER
If you forget any of the 7 green "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.

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 "ACTIVE" PILL EACH DAY until you can reach your healthcare provider.

INSTRUCTIONS FOR USE DIALPAK ® Tablet Dispenser

1. The DIALPAK comes to you set up for Sunday Start. If your physician has instructed you to start pill-taking
on the first SUNDAY after your menstrual period has begun, see directions in Number 3.

2. If you are to start pill-taking on a day other than SUNDAY, the enclosed calendar label has been provided and will be placed over the calendar printed on the plastic in the center of the DIALPAK. To put label in place, identify your correct starting day, locate that day on the label, line that day up with the pill to which the word START and the black Day Arrow are pointing, remove the label from the backing and press the label over the printed calendar on the center plastic.

3. When the compact is open with the cover at top, the pills should be arranged as they are in the picture. If not, turn the ribbed outer ring until the pills are positioned correctly.


ORTHO-NOVUM 7/ 7/ 7: There are 7 white "active" pills, 7 light peach "active" pills, 7 peach "active" pills and 7 green "reminder" pills.


ORTHO-NOVUM 10/ 11: There are 10 white "active" pills, 11 peach "active" pills and 7 green "reminder" pills.
ORTHO-NOVUM 1/ 35: There are 21 peach "active" pills and 7 green "reminder" pills.
MODICON: There are 21 white "active" pills and 7 green "reminder" pills.

4. The first pill you will take is indicated by START and lines up with the black Day Arrow in the center of the DIALPAK. If not, see the directions in Number 3.

5. Push down on the first pill with your thumb or forefinger. The pill will come out through a hole in the back of the package.

6. The next day, turn the DIAL to the right using the ribbed outer ring to the next pill and your second pill is ready to be taken.

7. After you have taken all 21 pills, take one green pill daily for 7 days. During this time your period should begin.

8. After you have taken all the pills, start a new pack of pills even if your period is not yet over.


HOW TO INSERT REFILL (ORTHO-NOVUM 7/ 7/ 7 ONLY)
1. Lift the empty refill out of the DIALPAK. Insert the new refill by placing the black tab on refill into the open-ing in the ribbed outer ring of the DIALPAK (see drawing).


2. Press the refill down so that it fits firmly under the nibs. The DIAL should be turned by the ribbed outer ring so that the tablets are again arranged as in the drawing. The first white tablet will be directly over the black
DAY ARROW.

DETAILED PATIENT LABELING

PLEASE NOTE: This labeling is revised from time to time as important new medical information becomes available. Therefore, please review this labeling carefully.

The following oral contraceptive products contain a combination of an estrogen and progestogen, the two kinds of female hormones:
ORTHO-NOVUM ® 7/ 7/ 7
Each white tablet contains 0.5 mg norethindrone and 0.035 mg ethinyl estradiol. Each light peach tablet con-tains 0.75 mg norethindrone and 0.035 mg ethinyl estradiol. Each peach tablet contains 1 mg norethindrone
and 0.035 mg ethinyl estradiol. Each green tablet contains inert ingredients.
ORTHO-NOVUM ® 10/ 11
Each white tablet contains 0.5 mg norethindrone and 0.035 mg ethinyl estradiol. Each peach tablet contains 1 mg norethindrone and 0.035 mg ethinyl estradiol. Each green tablet contains inert ingredients.

ORTHO-NOVUM ® 1/ 35
Each peach tablet contains 1 mg norethindrone and 0.035 mg ethinyl estradiol. Each green tablet contains inert ingredients.

MODICON ®
Each white tablet contains 0.5 mg norethindrone and 0.035 mg ethinyl estradiol. Each green tablet contains inert ingredients.


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