Acetaminophen (a-seet-a-MIN-oh-fen), Codeine Phosphate (KOE-deen FOS-fate)

Treats mild to moderately severe pain. This medicine contains a narcotic pain reliever.

Brand Name(s):

Tylenol With Codeine No. 4, Tylenol with Codeine No. 3

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Liquid, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• You may take this medicine with food or milk if it upsets your stomach.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• Drink plenty of liquids to help avoid constipation.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the oral liquid in the refrigerator. Do not freeze. Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website:www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.
• Some medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
  • Amiodarone, carbamazepine, erythromycin, ketoconazole, mirtazapine, phenytoin, quinidine, rifampin, ritonavir, tramadol, trazodone
  • Diuretic (water pill)
  • Medicine to treat depression (including bupropion, fluoxetine, paroxetine, quinidine, TCAs)
  • Phenothiazine medicine
  • Triptan medicine to treat migraine headaches
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are using buprenorphine, butorphanol, nalbuphine, pentazocine, or a muscle relaxer (including cyclobenzaprine, metaxalone).
• Do not drink alcohol while you are using this medicine. Acetaminophen can damage your liver, and alcohol can increase this risk. Do not take acetaminophen without asking your doctor if you have 3 or more drinks of alcohol every day.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, adrenal problems (including Addison disease), or breathing problems (including sleep apnea). Tell your doctor if you have an enlarged prostate, trouble urinating, stomach problems, an underactive thyroid, or a history of head injury or brain damage. Tell your doctor if you had an allergic reaction to sulfites or if you have a history of drug or alcohol abuse.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Sleep-related breathing problems (including sleep apnea, sleep-related hypoxemia)
  • Serotonin syndrome (when used with certain medicines)
  • Serious skin reactions
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine contains acetaminophen. Read the labels of all other medicines you are using to see if they also contain acetaminophen, or ask your doctor or pharmacist. Do not use more than 4 grams (4,000 milligrams) total of acetaminophen in one day.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, muscle spasms, twitching, diarrhea, seeing or hearing things that are not there
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Extreme drowsiness or confusion
• Extreme weakness, shallow breathing, slow heartbeat, sweating, seizures, cold or clammy skin
• Lightheadedness, dizziness, or fainting
• Trouble breathing, blue lips or nails
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Mild dizziness or drowsiness
• Mild nausea or vomiting, constipation

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088