Classes
DEA Class; OTC
Common Brand Names; Excedrin PM, Tylenol PM, Percogesic, Percogesic Extra Strength, Goody’s PM, Midol PM
- Cough/Cold, Non-narcotic Combos
Description
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
Indications
For the pain with Insomnia
Contraindications
Hypersensitivity
Use within 14 days of MAO inhibitor therapy
G-6-PD deficiency
Severe hepatic impairment
<12 years
Adverse Effects
Hypotension
Tachycardia
Sedation
Sleepiness
Dermatologic rash
Increased appetite
Xerostomia
Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)
Bilirubin and alkaline phosphatase may increase
Urinary retention
Warnings
Severe liver damage may occur with >4 g/24hr acetaminophen or consuming >3 alcoholic drinks daily while taking acetaminophen; patients should limit alcohol to <3 drinks/day
Not for use with any other drug containing acetaminophen (prescription or nonprescription); 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 acetaminophen sue in self-medication may result in toxicity due to cumulative doses that exceed recommended maximum dose
Patients should contact healthcare provider before self-medicating if patient currently has chronic bronchitis, emphysema, glaucoma, enlarged prostate, or are currently taking sedative drugs or alcohol
Acetaminophen may cause severe skin reactions, including skin reddening, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome, blisters, or rash; discontinue use of skin reactions occur
Patients should contact healthcare professional before taking the blood-thinning drug warfarin, or before taking sedatives or tranquilizers
Diphenhydramine may cause significant confusional symptoms; not for administration to premature or full-term neonates
Not for use with any other drug containing diphenhydramine; even when used on skin
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
Maximum Dosage
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
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
How supplied
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)