Dosing & Uses
Dosage Forms & Strengths
acetaminophen/pamabrom/pyridoxine
capsule
- 500mg/25mg/50mg
Analgesia/Menstrual Cramps
1 capsule PO q4-6hr PRN
Safety and efficacy not established
Adverse Effects
Frequency Not Defined
Angioedema
Laryngeal edema
Pruritic maculopapular rash
Urticaria
Agranulocytosis
Leukopenia
Neutropenia
Pancytopenia
Thrombocytopenia
Thrombocytopenic purpura
Hepatotoxicity
Anaphylactoid reaction
Warnings
Contraindications
Hypersensitivity
Hepatitis or severe hepatic/renal impairment
Repeated administration in patients with anemia, cardia, pulmonary, or renal disease
Cautions
Risk of hepatotoxicity; higher in alcoholics, or with use of more than 1 acetaminophen-containing product
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
G6PD deficiency
Pregnancy & 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
Mechanism of Action
Acetaminophen: Acts on hypothalamus to produce antipyresis
Pamabrom: Weak diuretic action
Pyridoxine: Vitamin B6 supplement