acetaminophen/diphenhydramine (Excedrin PM, Tylenol PM, Percogesic, Percogesic Extra Strength, Goody's PM, Midol PM)

Dosing and uses of Excedrin PM, Tylenol PM (acetaminophen/diphenhydramine)

• Adult
• Pediatric

 

Adult dosage forms and strengths

acetaminophen/diphenhydramine

tablet

• 325mg acetaminophen/12.5mg diphenhydramine hydrochloride (Percogesic)
• 325mg acetaminophen/50mg diphenhydramine hydrochloride (Unisom PM Pain Sleep Caps)
• 500mg acetaminophen/25mg diphenhydramine hydrochloride (Midol PM, Excedrin PM, Tylenol PM)
• 500mg acetaminophen/38mg diphenhydramine citrate (Midol PM, Excedrin PM, Tylenol PM)
• 500mg acetaminophen/12.5mg diphenhydramine hydrochloride (Percogesic Extra Strength, Tylenol Severe Allergy)

caplet

• 500mg acetaminophen/38mg diphenhydramine citrate (Excedrin PM)
• 500mg acetaminophen/50mg diphenhydramine hydrochloride (Legatrin PM)
• 500mg acetaminophen/25mg diphenhydramine hydrochloride (Mapap PM, Tylenol PM)
• 325mg acetaminophen/12.5mg diphenhydramine hydrochloride (Percogesic)

liquid

• 500mg acetaminophen/25mg diphenhydramine hydrochloride)/15mL (Tylenol PM)

gelcap

• 500mg acetaminophen/25mg diphenhydramine hydrochloride (Tylenol PM)

geltaB

• 500mg acetaminophen/25mg diphenhydramine hydrochloride (Tylenol PM)
• 500mg acetaminophen/38mg diphenhydramine citrate (Excedrin PM)

oral powder

• 500mg acetaminophen/38mg diphenhydramine citrate per packet (Goody's Powder PM)

 

Pain with Sleeplessness

Excedrin Pm

• 2 tabs/caps PO qHS

Tylenol Pm

• 2 tabs/caps/geltabs/gelcaps PO qHS

Goody's Pm

• 2 packets PO qHS PRN; may mix powders into glass or water or other liquid

Midol Pm

• 2 tabs PO qHS PRN

Percogesic

• 1-2 tabs/caps PO q4hr PRN

Unisom

• 1 tab PO qHS

 

Pediatric dosage forms and strengths

acetaminophen/diphenhydramine

tablet

• 325mg acetaminophen/12.5mg diphenhydramine hydrochloride (Percogesic)
• 325mg acetaminophen/50mg diphenhydramine hydrochloride (Unisom PM Pain Sleep Caps)
• 500mg acetaminophen/25mg diphenhydramine hydrochloride (Midol PM, Excedrin PM, Tylenol PM)
• 500mg acetaminophen/38mg diphenhydramine citrate (Midol PM, Excedrin PM, Tylenol PM)
• 500mg acetaminophen/12.5mg diphenhydramine hydrochloride (Percogesic Extra Strength, Tylenol Severe Allergy)

caplet

• 500mg acetaminophen/38mg diphenhydramine citrate (Excedrin PM)
• 500mg acetaminophen/50mg diphenhydramine hydrochloride (Legatrin PM)
• 500mg acetaminophen/25mg diphenhydramine hydrochloride (Mapap PM, Tylenol PM)
• 325mg acetaminophen/12.5mg diphenhydramine hydrochloride (Percogesic)

liquid

• 500mg acetaminophen/25mg diphenhydramine hydrochloride)/15mL (Tylenol PM)

gelcap

• 500mg acetaminophen/25mg diphenhydramine hydrochloride (Tylenol PM)

geltaB

• 500mg acetaminophen/25mg diphenhydramine hydrochloride (Tylenol PM)
• 500mg acetaminophen/38mg diphenhydramine citrate (Excedrin PM)

oral powder

• 500mg acetaminophen/38mg diphenhydramine citrate per packet (Goody's Powder PM)

 

Pain with Sleeplessness

Excedrin Pm

• <12 years: Safety and efficacy not established
• ≥12 years: 2 tabs/caps PO qHS

Tylenol Pm

• <12 years: Safety and efficacy not established
• ≥12 years: 2 tabs/caps/geltabs/gelcaps PO qHS

Goody's Pm

• <12 years: Safety and efficacy not established
• ≥12 years: 2 packets PO qHS PRN; may mix powders into glass or water or other liquid

Midol Pm

• <12 years: Safety and efficacy not established
• ≥12 years: 2 tabs PO qHS PRN

Percogesic

• <12 years: Safety and efficacy not established
• ≥12 years: 1-2 tabs/caps PO q4hr PRN

Unisom

• 1 tab PO qHS

 

Excedrin PM, Tylenol PM (acetaminophen/diphenhydramine) adverse (side) effects

Frequency not defined

Hypotension

Tachycardia

Sedation

Sleepiness

Dermatologic rash

Increased appetite

Xerostomia

Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)

Bilirubin and alkaline phosphatase may increase

Urinary retention

 

Warnings

Contraindications

Hypersensitivity

Use within 14 days of MAO inhibitor therapy

G-6-PD deficiency

Severe hepatic impairment

 

Cautions

Acetaminophen: Hepatotoxicity possible in chronic alcoholics following various dose levels; severe or recurrent pain or high or continued fever may indicate a serious illness; contained in many OTC products and combined use with these products may result in toxicity due to cumulative doses exceeding recommended maximum dose

Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash

Diphenhydramine: May cause significant confusional symptoms; not for administration to premature or full-term neonates

 

Pregnancy and lactation

Pregnancy category: C

Lactation: excreted in breast milk, use caution

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Excedrin PM, Tylenol PM (acetaminophen/diphenhydramine)

Mechanism of action

Acetaminophen blocks pain impulse generation peripherally & may inhibit the generation of prostaglandin in the CNS; reduces fever by inhibiting the hypothalamic heat-regulating center

Diphenhydramine competitively blocks histamine from binding to H1 receptors; significant antimuscarinic activity & penetrates CNS, which causes pronounced tendency to induce sedation

 

Pharmacokinetics

Acetaminophen

• Peak plasma time: 10-60 min (PO immediate release); 60-120 min (PO extended release); 6 hr (PO 500 mg tablet); 8 hr (PO 650 mg extended release tablet)
• Vd: 1 L/kg
• Protein binding: 10-25%
• Metabolism: Liver (microsomal enzyme systems); conjugation (glucuronic acid)
• Half-life: 1.25-3hr
• Excretion: Urine

Diphenhydramine

• Bioavailability: 42-62% (PO)
• Onset: 15-30 min
• Duration: 4-6 hr
• Peak plasma time: 2 hr (PO)
• Protein bound: 98.5%
• Vd: 22 L/kg (children); 17 L/kg (adults); 14 L/kg (Elderly)
• Half-life: 5 hr (children); 9 hr (adults); 13.5 hr (elderly)
• Excretion: Urine (50-75%)