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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

Oral Tablets: Single doses in the range of acetaminophen 300 mg to 1000 mg-codeine 15 mg to 60 mg orally up to every 4 hours as needed
Oral Solution: 15 mL (acetaminophen 360 mg-codeine 36 mg) orally every 4 hours as needed
Maintenance dose: Adjust according to the severity of pain and response of the patient
Maximum dose: acetaminophen 4000 mg-codeine 360 mg per 24-hours

Comments: Codeine doses higher than 60 mg have not been shown to provide greater pain relief, but are associated with an increased incidence of side effects.

Use: For the relief of mild to moderately severe pain.

Usual Pediatric Dose for Pain

Age: 3 to 6 years: acetaminophen 120 mg-codeine 12 mg (5 mL) orally 3 or 4 times a day

Age: 7 to 12 years: acetaminophen 240 mg-codeine 24 mg (10 mL) orally 3 or 4 times a day

Age greater than 12 years: acetaminophen 360 mg-codeine 36 mg (15 mL) orally every 4 hours as needed not to exceed acetaminophen 4000 mg-codeine 360 mg per 24-hours

Comments: The recommended dose of codeine in children is 0.5 mg/kg of body weight.

Use: For the relief of mild to moderately severe pain.

Renal Dose Adjustments

Severe renal impairment: Use with caution; monitor therapy with renal function tests

Liver Dose Adjustments

Severe hepatic impairment: Use with caution; monitor therapy with liver function tests

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.


-Hepatotoxicity: Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with use of acetaminophen at doses that exceed 4000 mg per day, and often involve more than 1 acetaminophen-containing product.
-Death Related to Ultra-Rapid Metabolism of Codeine to Morphine: Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to CYP450 2D6 polymorphism.

Safety and efficacy have not been established in patients younger than 3 years.

Consult WARNINGS section for additional precautions.

Tablets: US Controlled Substance: Schedule III
Oral Liquid and Oral Suspension: US Controlled Substance: Schedule V


Data not available

Other Comments

Administration advice:
-Take orally with or without food

-Most cases of liver injury associated with use of acetaminophen are at doses exceeding 4000 mg per day and often involve use of more than 1-acetaminophen-containing product.
-When treating pain, dose recommendations should be considered suggested approaches to what is actually a series of clinical decisions over time in the management of each individual patient.
-While initiating and titrating pain medications, patients should be under close medical supervision; for patients on longer-term therapy, routinely reassess for side effects associated with therapy and the need for continued opioid therapy.
-Patients who are ultra-rapid metabolizers of codeine due to a CYP450 2D6 polymorphism, will convert codeine more rapidly and completely to morphine resulting in unexpectedly high morphine levels, which may be life-threatening; children may be more susceptible to these effects.

-Respiratory: Monitor for respiratory depression
-Gastrointestinal: Monitor for constipation and decreased bowel motility in post-operative patients.
-General: Monitor routinely for maintenance of pain control and incidence of adverse reactions.
-Psychiatric: Patients should be monitored for the development of addiction, abuse, or misuse.

Patient advice:
-Patients should understand that this product contains acetaminophen and they should not be taking other products containing acetaminophen with this drug; if more than 4000 mg of acetaminophen is ingested in a 24-hour period, they should contact their healthcare provider promptly.
-Patients should understand the risks of life-threatening respiratory depression and when this risk is greatest, patients should be aware that a genetic mutation may result in greater toxicity in some patients.
-For women who are breastfeeding and have this genetic mutation, their infant will be at risk for morphine toxicity; nursing mothers should be instructed to seek immediate medical attention for infants experiencing increased sleepiness, difficulty breastfeeding, breathing difficulties, or limpness.
-Women of child bearing potential should understand that prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome and that prompt recognition and treatment will be necessary.
-This drug may cause drowsiness, dizziness, or impair thinking or motor skills; patients should avoid driving or operating machinery until adverse effects are determined.
-Advise patients to store this drug safely out of the sight and reach of children; patients should be instructed in proper disposal.