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acetaminophen/phenylephrine/guaifenesin (Theraflu Warming Relief Cold and Chest Congestion, Tylenol Sinus Congestion and Pain Severe, Sudafed PE Triple Action, Mucinex Fast-Max Cold and Sinus)

 

Classes: Cough/Cold, Other Combos; Analgesic/Decongestant/Expectorant Combos

Dosing and uses of Theraflu Warming Relief Cold and Chest Congestion, Tylenol Sinus Congestion and Pain Severe (acetaminophen/phenylephrine/guaifenesin)

 

Adult dosage forms and strengths

acetaminophen/phenylephrine/guaifenesin

tablet

  • 325mg/5mg/200mg

oral solution

  • (325mg/5mg/200mg)/15mL
  • (162.5mg/5mg/2.5mg/100mg)/5mL

 

Temporary Relief of Sinus Congestion, Headache, Minor Aches & Pains

2 tabs PO q4hr; not to exceed 12 tabs/24hr; not to exceed 1g/hr or 4g/day of acetaminophen

30 mL [(325mg/5mg/200mg)/15mL] PO q4hr

20 mL [(162.5mg/5mg/2.5mg/100mg)/5mL] PO q4hr

 

Pediatric dosage forms and strengths

acetaminophen/phenylephrine/guaifenesin

tablet

  • 325mg/200mg/5mg

oral solution

  • (325mg/5mg/200mg)/15mL
  • (162.5mg/5mg/2.5mg/100mg)/5mL

 

Temporary Relief of Sinus Congestion, Headache, Minor Aches & Pains

<12 years: Ask a pediatrician

≥12 years

  • 2 tabs PO q4hr; not to exceed 12 tabs/24hr; not to exceed 1g/hr or 4g/day of acetaminophen
  • 30 mL [(325mg/5mg/200mg)/15mL] PO q4hr
  • 20 mL [(162.5mg/5mg/2.5mg/100mg)/5mL] PO q4hr

 

Theraflu Warming Relief Cold and Chest Congestion, Tylenol Sinus Congestion and Pain Severe (acetaminophen/phenylephrine/guaifenesin) adverse (side) effects

Frequency not defined

Hypertension

Severe peripheral and visceral vasoconstriction

Tachycardia

Dizziness

Drowsiness

Excitability

Headache

Restlessness

Tremor

Dermatologic rash

Nausea

Vomiting

Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)

Bilirubin and alkaline phosphatase may increase

 

Warnings

Contraindications

Hypersensitivity

G-6-PD deficiency

Severe hepatotoxicity

 

Cautions

Phenylephrine: Caution in elderly patients, hyperthyroidism, myocardial disease, bradycardia, partial heart block or severe arteriosclerosis

Acetaminophen: Hepatotoxicity possible in chronic alcoholics following various dose levels; 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 may result in toxicity due to cumulative doses exceeding recommended maximum dose

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

Guaifenesin: not for administration in persistent cough associated with chronic bronchitis, smoking, asthma, or accompanied with excessive secretions

 

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

 

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 Theraflu Warming Relief Cold and Chest Congestion, Tylenol Sinus Congestion and Pain Severe (acetaminophen/phenylephrine/guaifenesin)

Mechanism of action

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.

 

Pharmacokinetics

Acetaminophen

  • Peak plasma time: 10-60 min (PO immediate release); 60-120 min (PO extended release); 6 hr (PO 500 mg tablet); 8 hr (PO 650 mg extended release tablet)
  • Vd: 1 L/kg
  • Protein binding: 10-25%
  • Metabolism: Liver (microsomal enzyme systems); conjugation (glucuronic acid)
  • Half-life: 1.25-3hr
  • Excretion: Urine

Phenylephrine

  • Half-life: 2-3 hr
  • Onset: 10-15 min
  • Duration: 15 min
  • Bioavailability: < 38%
  • Excretion: Urine (80-90%)
  • Peak plasma time: 0.75-2 hr
  • Vd: 26-61 L
  • Vdss: 340 L

Guaifenesin

  • Half-Life: 1 hr
  • Onset: 30 min
  • Duration: 4-6 hr
  • Metabolism: Liver
  • Metabolite: b-(2-methoxyphenoxy) lactic acid
  • Excretion: Urine