Self-medication in children ≥6 years of age and adults for the temporary relief of minor aches and pain associated with headache, muscular aches, backache, minor arthritis pain, common cold, toothache, and menstrual cramps. Self-medication in infants and children for the temporary relief of minor aches and pain associated with the common cold, flu, headache, sore throat, immunizations, toothache, muscle aches, sprains, and overexertion.
Self-medication in fixed combination with aspirin and caffeine for the temporary relief of mild to moderate pain associated with migraine headache. This combination also can be used for the treatment of severe migraine headache if previous attacks have responded to similar nonopiate analgesics or NSAIAs.
Symptomatic treatment of pain associated with osteoarthritis; considered an initial drug of choice for pain management in osteoarthritis patients.
Used in fixed combination with isometheptene and dichloralphenazone for symptomatic relief of tension and vascular headaches.
Self-medication to reduce fever in infants, children, and adults.
Dosage and Administration
Administration
Usually administered orally; may be administered rectally as suppositories in patients who cannot tolerate oral therapy.
Oral Administration
Swallow extended-release tablets whole; do not crush, chew, or dissolve in liquid.
Place orally disintegrating, fixed-combination acetaminophen/caffeine tablets on the tongue to dissolve; swallow with saliva. For best taste, do not chew.
Because combinations and dosage strengths vary for fixed-combination preparations, consult manufacturer’s product labeling for appropriate dosage of the specific preparation.
Pediatric Administration
Acetaminophen oral drops generally used in infants 0–23 months of age. Use the calibrated dosing device provided by the manufacturer for measurement of the dose.
Oral suspension may be used in children ≥4 months age. Use the calibrated dosage cup provided by the manufacturer for measurement of the dose.
80-mg chewable tablets or orally disintegrating tablets may be used in children ≥2 years of age.
160-mg chewable tablets or orally disintegrating tablets or 325-mg conventional tablets commonly used in children ≥6 years of age.
Orally disintegrating tablets (Tylenol® Meltaways) should be allowed to dissolve in the mouth or should be chewed before swallowing. Use caution to ensure that the correct number of tablets required for the intended dose is removed from the blister package.
Rectal Administration
Dividing suppositories in an attempt to administer lower dosages may not provide a predictable dose.
Some experts state that rectal acetaminophen preparations should not be used for self-medication in children unless such use is specifically discussed with a clinician and parents or caregivers are instructed to adhere to dosage and administration recommendations.
Dosage
Pediatric Patients
Dosage in children should be guided by body weight. (See Pediatric Use under Cautions.)
Pain
Oral
Dosage for Self-medication of Pain in Children up to 11 Years of Age
Age
Weight
Oral Dose
≤3 months
2.7–5 kg
40 mg
4–11 months
5–8 kg
80 mg
12–23 months
8–11 kg
120 mg
2–3 years
11–16 kg
160 mg
4–5 years
16–21.5 kg
240 mg
6–8 years
21.5–27 kg
320 mg
9–10 years
27–32.5 kg
400 mg
11 years
32.5–43 kg
480 mg
Dose may be given every 4–6 hours as necessary (up to 5 times in 24 hours).
For self-medication in children ≥12 years of age, 650 mg or 1 g every 4–6 hours as necessary (maximum 4 g daily).
Rectal
Dosage for Self-medication of Pain in Children 2–12 Years of Age
Age
Rectal Dose
2–4 years
160 mg
4–6 years
240 mg
6–9 years
320 mg
9–11 years
320–400 mg
11–12 years
320–480 mg
Dose may be given every 4–6 hours as necessary (up to 5 times in 24 hours).
Individualize dosage in children <2 years of age.
For self-medication in children ≥12 years of age, 325–650 mg every 4 hours as necessary.
Fever
Oral
Dosage for Self-medication of Fever in Children up to 11 Years of Age
Age
Weight
Oral Dose
≤3 months
2.7–5 kg
40 mg
4–11 months
5–8 kg
80 mg
12–23 months
8–11 kg
120 mg
2–3 years
11–16 kg
160 mg
4–5 years
16–21.5 kg
240 mg
6–8 years
21.5–27 kg
320 mg
9–10 years
27–32.5 kg
400 mg
11 years
32.5–43 kg
480 mg
Dose may be given every 4–6 hours as necessary (up to 5 times in 24 hours).
For self-medication in children ≥12 years of age, 650 mg or 1 g every 4–6 hours as necessary (maximum 4 g daily).
Rectal
Dosage for Self-medication of Fever in Children 2–12 Years of Age
Age
Rectal Dose
2–4 years
160 mg
4–6 years
240 mg
6–9 years
320 mg
9–11 years
320–400 mg
11–12 years
320–480 mg
Dose may be given every 4 hours as necessary (up to 5 times in 24 hours).
Individualize dosage in children <2 years of age.
For self-medication in children ≥12 years of age, 325–650 mg every 4 hours as necessary.
Adults
Pain
Oral
For self-medication, 650 mg or 1 g every 4–6 hours as necessary (maximum 4 g daily). Alternatively, 1.3 g as extended-release tablets every 8 hours.
Rectal
325–650 mg every 4 hours as necessary.
Pain Associated with Migraine Headache
Oral
Acetaminophen, aspirin, and caffeine for self-medication: 2 tablets (each containing acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) as a single dose.
Acetaminophen, dichloralphenazone, and isometheptene mucate: 2 capsules (each containing acetaminophen 325 mg, dichloralphenazone 100 mg, and isometheptene mucate 65 mg) initially, followed by 1 capsule every hour until headache relieved (maximum 5 capsules in 12 hours).
Pain Associated with Tension Headache
Oral
Acetaminophen, dichloralphenazone, and isometheptene mucate: 1 or 2 capsules (each containing acetaminophen 325 mg, dichloralphenazone 100 mg, and isometheptene mucate 65 mg) every 4 hours (up to 8 capsules daily).
Pain Associated with Osteoarthritis
Oral
1 g 4 times daily. Alternatively, 1.3 g as extended-release tablets every 8 hours.
Fever
Oral
For self-medication, 650 mg or 1 g every 4–6 hours as necessary (maximum 4 g daily).
Rectal
325–650 mg every 4 hours as necessary.
Prescribing Limits
Pediatric Patients
Pain
Oral
Do not exceed recommended daily dosage. Self-medication should not exceed 5 days.
Fever
Oral
Do not exceed recommended daily dosage. Self-medication should not exceed 3 days.
Adults
Current limit is 4 g daily. Some experts recommend a maximum dosage of 3 g daily when used for long-term therapy (e.g., ≥2 weeks). FDA is evaluating whether data exist to support establishing a lower (i.e., <4 g daily) maximum daily dosage for certain patients (e.g., those who chronically ingest alcohol).
Pain
Oral or Rectal
Maximum 4 g daily. Self-medication should not exceed 10 days.
Pain Associated with Migraine Headache
Oral
Acetaminophen, aspirin, and caffeine: Maximum for self-medication is 2 tablets (each containing acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) in 24 hours unless otherwise directed by a clinician.
Acetaminophen, dichloralphenazone, and isometheptene mucate: Maximum 5 capsules (each containing acetaminophen 325 mg, dichloralphenazone 100 mg, and isometheptene mucate 65 mg) in 12 hours.
Pain Associated with Tension Headache
Oral
Acetaminophen, dichloralphenazone, and isometheptene mucate: Maximum 8 capsules (each containing acetaminophen 325 mg, dichloralphenazone 100 mg, and isometheptene mucate 65 mg) in 24 hours.
Pain Associated with Osteoarthritis
Oral
Maximum 4 g daily.
Fever
Oral or Rectal
Maximum 4 g daily. Self-medication should not exceed 3 days.
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