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Acetaminophen / Codeine Dosage

Applies to the following strength(s): 325 mg-30 mg ; 325 mg-60 mg ; 120 mg-12 mg/5 mL ; 300 mg-15 mg ; 300 mg-30 mg ; 300 mg-60 mg ; 650 mg-30 mg ; 650 mg-60 mg

The information at is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Pain

Initial dose: 1 tablet (acetaminophen 300 mg/codeine 30 mg or acetaminophen 650 mg/codeine 60 mg) or 15 mL liquid orally every 4 hours as needed
Single Dose (Range): Codeine 15 mg to 60 mg/Acetaminophen 300 mg to 1000 mg. Doses may be repeated up to every 4 hours.
Maximum 24 Hour Dose: Codeine 360 mg/Acetaminophen 4000 mg

Usual Adult Dose for Cough

Initial dose: 1 tablet (acetaminophen 300 mg/codeine 15 to 30 mg) or 5 to 10 mL liquid orally every 4 to 6 hours as needed.

Usual Pediatric Dose for Pain

3 to 6 years: 5 mL orally 3 to 4 times a day as needed
7 to 11 years: 10 mL orally 3 to 4 times a day as needed
Greater than or equal to 12 years: 15 mL orally every 4 hours as needed

Renal Dose Adjustments

Use with caution in patients diagnosed with severe renal impairment.

Liver Dose Adjustments

Use with caution in patients diagnosed with severe hepatic impairment.

Dose Adjustments

Dosage should be adjusted according to severity of pain and response of the patient. Doses of codeine >60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects.


Use with caution in certain patients such as the elderly or debilitated, and those with hypothyroidism, Addison's disease, and prostatic hypertrophy or urethral stricture.

Codeine, particularly in large doses, may cause life-threatening respiratory depression. Treatment includes maintenance of the airway, artificial ventilation if necessary, and the opiate antagonist, naloxone. (The usual adult dose of naloxone is 1 to 2 mg every 5 minutes as necessary to a maximum of 10 mg. The dose can be administered intravenously, intramuscularly, subcutaneously and sublingually.)

Codeine, like other narcotic analgesics, should generally be avoided in patients with sleep apnea syndrome, head injuries, increased intracranial pressure, anoxia, acute undiagnosed abdominal pain, hypothyroidism, severe renal disease, severe liver disease, Addison's disease, bronchial asthma, acute alcoholism, respiratory depression, prostatic hypertrophy, urethral stricture, and general debilitation.

Codeine, like other narcotic analgesics, may be habit forming.

Patients who consume three or more alcohol containing drinks per day should be informed to consult with their physician for advice on when and how to take acetaminophen. Chronic, heavy alcohol users may be at increased risk of liver damage when taking more than recommended dosages.

FDA is reviewing reports of children who developed serious adverse effects or died after taking codeine for pain relief after tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome. Three pediatric deaths and one nonfatal but life-threatening case of respiratory depression were documented. These children (ages 2 to 5) had evidence of an inherited (genetic) ability to convert codeine into life-threatening or fatal amounts of morphine in the body (ultrarapid metabolizers). All children had received doses of codeine that were within the typical dose range. The lowest effective dose for the shortest period of time of any codeine containing drug should be used only on an as needed basis (i.e., not scheduled around the clock). Caregivers who observe unusual sleepiness, confusion, or difficult or noisy breathing in their child should seek medical attention immediately, as these are signs of overdose.


Use with caution in dialysis patients.

Other Comments

The FDA has asked manufacturers to limit the maximum amount of acetaminophen in prescription products to 325 mg per dosage unit. There are no data that indicate that taking more than 325 mg of acetaminophen per dosage unit provides more pain relief. The goal of the FDA is to reduce the risk of severe liver injury from acetaminophen overdose, which can lead to liver failure, liver transplant, and even death. The total number of units that may be prescribed and the time intervals for dosing will not change. Drug companies will have until January 14, 2014 to comply with FDA requirements.

Tolerance to codeine can develop with continued use and the incidence of untoward effects is dose related.