acetaminophen/pheniramine/phenylephrine (OTC)

Brand and Other Names:Theraflu Cold & Sore Throat, Theraflu Flu & Sore Throat
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

acetaminophen/pheniramine/phenylephrine

powder

  • 325mg/20mg/10mg per packet
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Allergy Symptoms & Common Cold

Dissolve contents of 1 packet in 8 oz of hot water; consume entire 8 oz within 10-15 minutes; not to exceed acetaminophen 1 g/dose or 4 g/day

Dosage Forms & Strengths

acetaminophen/pheniramine/phenylephrine

powder

  • 325mg/20mg/10mg per packet
more...

Allergy Symptoms & Common Cold

<12 years: Ask a pediatrician

≥12 years: Dissolve contents of 1 packet in 8 oz of hot water; consume entire 8 oz within 10-15 minutes; not to exceed acetaminophen 1 g/dose or 4 g/day

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Interactions

Interaction Checker

and acetaminophen/pheniramine/phenylephrine

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            Adverse Effects

            Frequency Not Defined

            Hypotension

            Palpitations

            Reflex hypertension

            Severe peripheral and visceral vasoconstriction

            Tachycardia

            Confusion

            Dizziness

            Depression

            Distress

            Euphoria

            Fatigue

            Headache

            Insomnia

            Irritability

            Restlessness

            Sedation

            Tremors

            Dermatologic rash

            Anorexia

            Agranulocytosis

            Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)

            Hemolytic anemia

            Thrombocytopenia

            Bilirubin and alkaline phosphatase may increase

            Thickening of bronchial secretions

            Wheezing

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            Warnings

            Contraindications

            Hypersensitivity

            Asthma

            < 2 years old

            Narrow-angle glaucoma

            Symptomatic prostate hypertrophy

            Bladder-neck obstruction

            Stenosing peptic ulcer

            Use within 14 days of MAO inhibitor therapy

            G-6-PD deficiency

            Severe hepatic impairment

            Cautions

            Pheniramine: May cause significant confusional symptoms; not for administration to premature or full-term neonates

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

            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

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            Pregnancy & Lactation

            Pregnancy: 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 prostaglandin generation in CNS; reduces fever by inhibiting the hypothalamic heat-regulating center

            Pheniramine: competes with histamine for histamine H1- receptor sites on effector cells; antihistamines antagonize the effects of histamine mediated through activation of H1- receptor sites, thereby reduces intensity of allergic reactions & tissue injury caused by histamine release

            Phenylephrine: vasoconstrictor & decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue; shrinks swollen mucous membranes, reduces nasal congestion & tissue hyperemia

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