Acetaminophen / Diphenhydramine Dosage

Medically reviewed by Drugs.com. Last updated on Sep 20, 2023.

Usual Adult Dose for Pain

Acetaminophen 325 mg/diphenhydramine 12.5 mg: 2 tablets orally every 4 to 6 hours as needed
Maximum dose: 8 tablets in 24-hours

Acetaminophen 500 mg/diphenhydramine 12.5 mg: 2 tablets orally every 6 hours as needed
Maximum dose: 6 tablets in 24-hours

Comments:

• The maximum total daily dose of acetaminophen should not exceed 4000 mg; when calculating daily dose, must account for all formulations of acetaminophen.

Uses:

• For temporary relief of minor aches and pains due to headache, backache, muscular aches, arthritis, pain, colds, flu, fever, toothache, premenstrual and menstrual cramps.
• For temporary relief of runny nose, sneezing, and itchy nose and throat.

Usual Adult Dose for Headache

Acetaminophen 325 mg/diphenhydramine 12.5 mg: 2 tablets orally every 4 to 6 hours as needed
Maximum dose: 8 tablets in 24-hours

Acetaminophen 500 mg/diphenhydramine 12.5 mg: 2 tablets orally every 6 hours as needed
Maximum dose: 6 tablets in 24-hours

Comments:

• The maximum total daily dose of acetaminophen should not exceed 4000 mg; when calculating daily dose, must account for all formulations of acetaminophen.

Uses:

• For temporary relief of minor aches and pains due to headache, backache, muscular aches, arthritis, pain, colds, flu, fever, toothache, premenstrual and menstrual cramps.
• For temporary relief of runny nose, sneezing, and itchy nose and throat.

Usual Adult Dose for Insomnia

Acetaminophen 1000 mg/diphenhydramine 50 mg orally at bedtime
Maximum dose: 1 dose in 24-hours

Comments:

• The maximum total daily dose of acetaminophen should not exceed 4000 mg; when calculating daily dose, must account for all formulations of acetaminophen.
• Diphenhydramine hydrochloride 25 mg is approximately equal to diphenhydramine citrate 38 mg; the above dosing is provided as diphenhydramine hydrochloride.

Use: For the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

Usual Pediatric Dose for Pain

12 years or older:
Acetaminophen 325 mg/diphenhydramine 12.5 mg: 2 tablets orally every 4 to 6 hours as needed
Maximum dose: 8 tablets in 24-hours

Acetaminophen 500 mg/diphenhydramine 12.5 mg: 2 tablets orally every 6 hours as needed
Maximum dose: 6 tablets in 24-hours

Comments:

• The maximum total daily dose of acetaminophen should not exceed 4000 mg; when calculating daily dose, must account for all formulations of acetaminophen.

Uses:

• For temporary relief of minor aches and pains due to headache, backache, muscular aches, arthritis, pain, colds, flu, fever, toothache, premenstrual and menstrual cramps.
• For temporary relief of runny nose, sneezing, and itchy nose and throat.

Usual Pediatric Dose for Headache

12 years or older:
Acetaminophen 325 mg/diphenhydramine 12.5 mg: 2 tablets orally every 4 to 6 hours as needed
Maximum dose: 8 tablets in 24-hours

Acetaminophen 500 mg/diphenhydramine 12.5 mg: 2 tablets orally every 6 hours as needed
Maximum dose: 6 tablets in 24-hours

Comments:

• The maximum total daily dose of acetaminophen should not exceed 4000 mg; when calculating daily dose, must account for all formulations of acetaminophen.

Uses:

• For temporary relief of minor aches and pains due to headache, backache, muscular aches, arthritis, pain, colds, flu, fever, toothache, premenstrual and menstrual cramps.
• For temporary relief of runny nose, sneezing, and itchy nose and throat.

Usual Pediatric Dose for Insomnia

12 years or older:
Acetaminophen 1000 mg/diphenhydramine 50 mg orally at bedtime
Maximum dose: 1 dose in 24-hours

Comments:

• The maximum total daily dose of acetaminophen should not exceed 4000 mg; when calculating daily dose, must account for all formulations of acetaminophen.
• Diphenhydramine hydrochloride 25 mg is approximately equal to diphenhydramine citrate 38 mg; the above dosing is provided as diphenhydramine hydrochloride.

Use: For the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

Renal Dose Adjustments

Use with caution, especially in patients with severe renal impairment

Liver Dose Adjustments

Use with caution; do not exceed recommended dose

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active substances or any product excipients
• Do not use with any other diphenhydramine-containing product, including topical products
• Do not use in children less than 12 years
• Should not use with any other acetaminophen-containing products

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally
• Enclosed dosing cup should be used to measure oral solution dose

Patient advice:

• Read the US FDA-approved patient labeling.
• Patients should be instructed to limit use of acetaminophen-containing products to one product at a time so they do not inadvertently exceed the daily acetaminophen limit.
• Patients should understand the importance of prompt medical care if they exceed the daily acetaminophen limit, even if they feel fine.
• Patients should understand this drug is for temporary relief; if pain worsens or lasts for longer than 10 days, fever gets worse or lasts more than 3 days, or sleeplessness persists for more than 2 weeks, they should contact their healthcare professional.
• Patients should understand that this drug causes drowsiness and they should not drive or operate hazardous machinery while taking this drug.
• Patients should limit their alcohol use while taking this drug.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer