acetaminophen/diphenhydramine (OTC)

Brand and Other Names:Excedrin PM, Tylenol PM, more...Percogesic, Percogesic Extra Strength, Goody's PM, Midol PM
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Dosing & Uses

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Dosing Form & 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

Dosing Form & 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
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Interactions

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and acetaminophen/diphenhydramine

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            Adverse 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

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            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

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            Pregnancy & 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.

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            Pharmacology

            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%)
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            Images

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