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ORTHO TRI CYCLEN Lo: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Boxed warning
Strength:
0.18 mg, 0.025 mg, 0.215 mg, 0.25 mg
Other brand names:
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - ORTHO TRI CYCLEN Lo

HOW TO TAKE THE PILL

IMPORTANT POINTS TO REMEMBER

BEFORE YOU START TAKING YOUR PILLS:

  1. 1.

    BE SURE TO READ THESE DIRECTIONS:

    Before you start taking your pills.

    Anytime you are not sure what to do.

  2. 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. 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 healthcare professional.
  4. 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. 5.

    IF YOU HAVE VOMITING OR DIARRHEA, or IF YOU TAKE SOME MEDICINES, including some antibiotics, your pills may not work as well.

    Use a back-up method (such as a condom or spermicide) until you check with your healthcare professional.

  6. 6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your healthcare professional about how to make pill-taking easier or about using another method of birth control.
  7. 7. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your healthcare professional.
BEFORE YOU START TAKING YOUR PILLS
  1. 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. 2. The 28-pill pack has 21 white, light blue, and dark blue "active" pills (with hormones) to take for 3 weeks. This is followed by 1 week of dark green "reminder" pills (without hormones).
  3. 3.

    ALSO FIND:

    • where on the pack to start taking pills,
    • in what order to take the pills.

CHECK PICTURE OF PILL PACK AND ADDITIONAL INSTRUCTIONS FOR USING THIS PACKAGE IN THE BRIEF SUMMARY PATIENT PACKAGE INSERT.

  1. 4.

    BE SURE YOU HAVE READY AT ALL TIMES:

    ANOTHER KIND OF BIRTH CONTROL (such as a condom 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

You have a choice of which day to start taking your first pack of pills. ORTHO TRI-CYCLEN® Lo is available with the DIALPAK® Tablet Dispenser which is preset for a Sunday Start. Day 1 Start is also provided. Decide with your healthcare professional which is the best day for you. Pick a time of day that will be easy to remember.

Sunday Start:

Take the first white "active" 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.

Use another method of birth control (such as a condom 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:

Take the first white "active" 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. 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. 2.

    When You Finish A Pack Or Switch Your Brand Of Pills

    Start the next pack on the day after your last dark green "reminder" pill. Do not wait any days between packs.

WHAT TO DO IF YOU MISS PILLS

If you MISS 1 white, light blue or dark blue "active" pill:

  1. 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. 2. You do not need to use a back-up birth control method if you have sex.

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

  1. 1. Take 2 pills on the day you remember and 2 pills the next day.
  2. 2. Then take 1 pill a day until you finish the pack.
  3. 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 a condom or spermicide) as a back-up method for those 7 days.

If you MISS 2 dark blue "active" pills in a row in THE 3RD WEEK:

  1. 1.

    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.

    If you are a Day 1 Starter:

    THROW OUT the rest of the pill pack and start a new pack that same day.

  2. 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 professional because you might be pregnant.
  3. 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 a condom or spermicide) as a back-up method for those 7 days.

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

  1. 1.

    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.

    If you are a Day 1 Starter:

    THROW OUT the rest of the pill pack and start a new pack that same day.

  2. 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 professional because you might be pregnant.
  3. 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 a condom or spermicide) as a back-up method for those 7 days.

If you forget any of the 7 dark 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 professional.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 021241 · View the label on DailyMed

Revision date stated in the text: June 2010

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for ORTHO TRI CYCLEN Lo

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Estrogen, Progestin
Active ingredients Norgestimate 0.18 mg / 0.25 mg / 0.215 mg, Ethinyl estradiol 0.025 mg
Dosage form Kit
Marketing status not in the current FDA NDC Directory
Company (applicant) JANSSEN PHARMS
FDA approval NDA 021241New Drug Application (NDA) Approved August 22, 2002
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Packages (NDC)
Package
0.18 mg, 0.025 mg, 0.215 mg, 0.25 mg – 1 in 1 blister pack NDC 54868-4730-0

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.