acetaminophen/phenylephrine/guaifenesin (OTC)

Brand and Other Names:Theraflu Warming Relief Cold & Chest Congestion, Tylenol Sinus Congestion & Pain Severe, more...Sudafed PE Triple Action, Mucinex Fast-Max Cold & Sinus
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

acetaminophen/phenylephrine/guaifenesin

tablet

  • 325mg/5mg/200mg

oral solution

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

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

Dosage Forms & Strengths

acetaminophen/phenylephrine/guaifenesin

tablet

  • 325mg/200mg/5mg

oral solution

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

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
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Interactions

Interaction Checker

and acetaminophen/phenylephrine/guaifenesin

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            Adverse 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

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            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

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            Pregnancy & 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.

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            Pharmacology

            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
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            Images

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