Classes
DEA Class; OTC
Common Brand Names; Phenagesic, AcetaGesic, Lagesic, PB Poly-650, Flextra DS, Phenylgesic, Relagesic Liquid, Staflex
- Analgesic/Other 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
Phenylephrine is a vasoconstrictor and decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue; shrinks swollen mucous membranes, reduces nasal congestion and tissue hyperemia
Guaifenesin increases respiratory tract fluid secretions and helps to loosen phlegm and bronchial secretions.
Indications
Indicated for Analgesia
Contraindications
Hypersensitivity to drugss or formulation components
Hepatitis or severe hepatic/renal impairment
Adverse Effects
Angioedema
Laryngeal edema
Sedation
Pruritic maculopapular rash
Urticaria
Xerostomia
Agranulocytosis
Leukopenia
Neutropenia
Pancytopenia
Thrombocytopenia
Thrombocytopenic purpura
Hepatotoxicity
Blurred vision
Anaphylactoid reaction
Warnings
Caution in G6PD deficiency
Consumption of 3 or more alcoholic beverages/day may increase risk for liver damage (associated with acetaminophen)
Do not take with other products that contain acetaminophen due to risk of additive toxicity/overdose
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
May cause CNS depression and impair ability to operate heavy machinery
May cause hepatotoxicity in acute overdose
Use caution in glaucoma, hepatic impairment, prostatic hyperplasia, respiratory disease, and renal impairment
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
1-2 tablets or capsules PO q4-6hr PRN
Products vary, see brand section & check specific labeling for each
Pediatric
Safety & efficacy not established
How supplied
acetaminophen/phenyltoloxamine
tablet
- 325mg/30mg
- 500mg/50mg
- 500mg/55mg
- 600mg/66mg
- 650mg/60mg