acetaminophen/phenylephrine (OTC)

Brand and Other Names:Excedrin Sinus Headache, Sinutab Sinus Maximum Strength Tablets, more...QlearQuil Daytime Sinus & Congestion Relief, Sine-Off Non-Drowsy Maximum Strength Tablets, Sudafed PE Sinus Headache, Robitussin Peak Cold Nasal Relief, Tylenol Infants Drops Plus Cold, Tylenol Sinus Congestion & Pain Daytime, Vicks DayQuil Sinus
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

acetaminophen/phenylephrine

caplets

  • 325mg/5mg
  • 500mg/5mg

tablet

  • 325mg/5mg
  • 500mg/5mg

capsule

  • 325mg/5mg

gelcap

  • 325mg/5mg
more...

Relief of Mild to Moderate Pain & Congestion, Flu Symptoms, Common Cold

650 mg/10 mg PO q4hr PRN; not to exceed 6 doses/24hr

1000 mg/10 mg PO q6hr PRN; not to exceet 4 doses/24hr

Dosage Forms & Strengths

acetaminophen/phenylephrine

caplets

  • 325mg/5mg
  • 500mg/5mg

tablet

  • 325mg/5mg
  • 500mg/5mg

capsule

  • 325mg/5mg

gelcap

  • 325mg/5mg
more...

Relief of Mild to Moderate Pain & Congestion, Flu Symptoms, Common Cold

<12 years: Ask a pediatrician

≥12 years

  • 650mg/10mg PO q4hr PRN; not to exceed 6 doses/24hr
  • 1000mg/10mg PO q6hr PRN; not to exceet 4 doses/24hr
Next:

Interactions

Interaction Checker

and acetaminophen/phenylephrine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            Frequency Not Defined

            Hypertension

            Reflex tachycardia

            Severe peripheral and visceral vasoconstriction

            Dizziness

            Excitability

            Headache

            Restlessness

            Tremor

            Dermatologic rash

            Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)

            Bilirubin and alkaline phosphatase

            Previous
            Next:

            Warnings

            Contraindications

            Both drugs contraindicated in documented hypersensitivity to either drug or components; known G-6-PD deficiency

            Cautions

            Caution in elderly patients, hyperthyroidism, myocardial disease, bradycardia, partial heart block or severe arteriosclerosis when administering phenylephrine; in hypovolemia, phenylephrine use is not a substitute for replacement of blood, fluids and electrolytes, and plasma (promptly restore with loss); dilute IV and administer via large vein; extravasation precautions required

            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

            Previous
            Next:

            Pregnancy & Lactation

            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.

            more...
            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Acetaminophen blocks pain impulse generation peripherally and may inhibit the generation of prostaglandin in the CNS. Reduces fever by inhibiting the hypothalamic heat-regulating center.

            Phenylephrine is a vasoconstrictor and a decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue. It shrinks swollen mucous membranes, reduces nasal congestion and tissue hyperemia.

            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
            Previous
            Next:

            Images

            Previous
            Next: