Dosing and uses of Midol Complete (acetaminophen/caffeine/pyrilamine)
Adult dosage forms and strengths
acetaminophen/caffeine/pyrilamine
caplet
- 500mg/60mg/15mg
Menstrual Symptoms
Indicated for temporary relief of symptoms associated with menstrual periods
2 caplets PO q6hr prn; not to exceed 8 caplets/day
Pediatric dosage forms and strengths
acetaminophen/caffeine/pyrilamine
caplet
- 500mg/60mg/15mg
Menstrual Symptoms
Indicated for temporary relief of symptoms associated with menstrual periods
<12 years: Safety and efficacy not established
12 years or older: 2 caplets PO q6hr prn; not to exceed 8 caplets/day
Midol Complete (acetaminophen/caffeine/pyrilamine) adverse (side) effects
Frequency not defined (acetaminophen)
Pruritic maculopapular rash
Urticaria
Laryngeal edema
Angioedema
Anaphylactoid reaction
Thrombocytopenia
Leukopenia
Pancytopenia
Neutropenia
Thrombocytopenic purpura
Agranulocytosis
Hepatotoxicity
Frequency not defined (caffeine)
Insomnia
Restlessness
Nervousness
Tremor
Tinnitus
Irritability
Nausea
Vomiting
Diarrhea
Tachycardia
Diuresis
Palpitations (dose dependent)
Frequency not defined (pyrilamine)
Sedation
Xerostomia
Blurred vision
Warnings
Contraindications
Hypersensitivity
Hepatitis or severe hepatic/renal impairment
Repeated administration in patients with anemia, cardiovascular, pulmonary, or renal disease
Cautions
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
Caution with glaucoma, difficulty in urination caused by prostate gland enlargement, and emphysema or chronic bronchitis
Additive sedation may occur if used with alcohol or sedative drugs
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
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
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 Midol Complete (acetaminophen/caffeine/pyrilamine)
Mechanism of action
Acetaminophen: Acts on hypothalamus to produce analgesia
Caffeine: Vasoconstrictive properties may be helpful when treating vascular headaches
Pyrilamine: Elicits mild diuretic properties
