TYLENOL with Codeine (Page 10 of 11)

Titration and Maintenance of Therapy

Individually titrate TYLENOL® with Codeine tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving TYLENOL® with Codeine tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse (see WARNINGS). Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the TYLENOL® with Codeine tablets dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

Discontinuation of TYLENOL® with Codeine

When a patient who has been taking TYLENOL® with Codeine tablets regularly and may be physically dependent no longer requires therapy with TYLENOL® with Codeine tablets, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue TYLENOL® with Codeine tablets in a physically-dependent patient (see WARNINGS, DRUG ABUSE AND DEPENDENCE).

HOW SUPPLIED

Product: 50090-0006

NDC: 50090-0006-2 20 TABLET in a BOTTLE

Manufactured by:
Janssen Ortho LLC
Gurabo, Puerto Rico 00778

Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560

Revised 09/2018

© 2000 Janssen Pharmaceutical Companies

Medication Guide
TYLENOL® (TAHY-luh-nawl) with Codeine Tablets, CIII
This Medication Guide has been approved by the U.S. Food and Drug Administration.
TYLENOL® with Codeine tablets are:
  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage mild to moderate pain, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Important information about TYLENOL® with Codeine tablets:
  • Get emergency help right away if you take too much TYLENOL® with Codeine tablets (overdose). When you first start taking TYLENOL® with Codeine tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
  • Taking TYLENOL® with Codeine tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma and death.
  • Never give anyone else your TYLENOL® with Codeine tablets. They could die from taking it. Store TYLENOL® with Codeine tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away TYLENOL® with Codeine tablets is against the law.

Important Information Guiding Use in Pediatric Patients:

  • Do not give TYLENOL® with Codeine tablets to a child younger than 12 years of age.
  • Do not give TYLENOL® with Codeine tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
  • Avoid giving TYLENOL® with Codeine tablets to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.
Do not take TYLENOL® with Codeine tablets if you have:
  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or narrowing of the stomach or intestines.
  • previously had an allergic reaction to codeine or acetaminophen.
Before taking TYLENOL® with Codeine tablets, tell your healthcare provider if you have a history of:
  • head injury, seizures
  • liver, kidney, thyroid problems
  • problems urinating
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems
  • have been told by your healthcare provider that you are a “rapid metabolizer” of certain medicines.
Tell your healthcare provider if you are:
  • pregnant or planning to become pregnant. Prolonged use of TYLENOL® with Codeine tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Not recommended; may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking TYLENOL® with Codeine with certain other medicines can cause serious side effects that could lead to death.
When taking TYLENOL® with Codeine tablets:
  • Do not change your dose. Take TYLENOL® with Codeine tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose every 4 hours as needed. Do not take more than your prescribed dose. If you miss a dose, take your next dose when needed.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking TYLENOL® with Codeine tablets regularly, do not stop taking TYLENOL® with Codeine tablets without talking to your healthcare provider.
  • After you stop taking TYLENOL® with Codeine tablets dispose of any unused tablets in accordance with local state guidelines and/or regulations.
While taking TYLENOL® with Codeine tablets DO NOT:
  • Drive or operate heavy machinery, until you know how TYLENOL® with Codeine tablets affect you. TYLENOL® with Codeine tablets can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with TYLENOL® with Codeine may cause you to overdose and die.
The possible side effects of TYLENOL® with Codeine tablets:
  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of TYLENOL® with Codeine tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.
Manufactured by: Janssen Ortho LLC, Gurabo, Puerto Rico 00778. Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560. 1-800-526-7736

Issued: August 2017

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