Classes
DEA Class; OTC
Common Brand Names; Midol Complete
Analgesics, Other combo
Description
Acetaminophen: Acts on hypothalamus to produce analgesia
Caffeine: Vasoconstrictive properties may be helpful when treating vascular headaches
Pyrilamine: Elicits mild diuretic properties
Indications
Indicated for temporary relief of symptoms associated with menstrual periods
Contraindications
Hypersensitivity to drug or components
Adverse Effects
Acetaminophen
Pruritic maculopapular rash
Urticaria
Laryngeal edema
Angioedema
Anaphylactoid reaction
Thrombocytopenia
Leukopenia
Pancytopenia
Neutropenia
Thrombocytopenic purpura
Agranulocytosis
Hepatotoxicity
Caffeine
Insomnia
Restlessness
Nervousness
Tremor
Tinnitus
Irritability
Nausea
Vomiting
Diarrhea
Tachycardia
Diuresis
Palpitations (dose dependent)
Pyrilamine
Sedation
Xerostomia
Blurred vision
Warnings
Risk of hepatotoxicity; risk is higher in alcoholics or with use of more than one acetaminophen-containing product
Caution regarding daily acetaminophen consumption; do not exceed 3-4 g/day and do not take for prolonged duration G6PD deficiency
May cause CNS depression, which may impair mental and physical abilities; caution patients about performing tasks requiring mental alertness, including operating heavy machinery
Caution with glaucoma, difficulty in urination caused by prostate gland enlargement, and emphysema or chronic bronchitis
Allergic reactions reported with acetaminophen; discontinue immediately if symptoms of allergic or hypersensitivity reactions occur
Additive sedation may occur if used with alcohol or sedative drugs
Acetaminophen associated with increased 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
Pregnancy and Lactation
Pregnancy category: C
Lactation: Excreted in breast milk
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
Maximum Dosage
2 caplets PO q6hr prn; not to exceed 6 caplets/day
Pediatric
<12 years: Safety and efficacy not established
12 years or older: 2 caplets PO q6hr prn; not to exceed 8 caplets/day
How supplied
acetaminophen/caffeine/pyrilamine
caplet
- 500mg/60mg/15mg