Drug Class: Analgesic combinations
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.
