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Ibuprofen/Phenylephrine

    Brands

    DEA Class; OTC

    Common Brand Names; Advil Congestion Relief

     Cough/Cold, Other Combos; Analgesic/Decongestant Combos

    Ibuprofen: Inhibits synthesis of prostaglandins by inhibiting cyclooxygenase (COX-1, COX-2); may inhibit chemotaxis, alter lymphocyte activity, decrease proinflammatory cytoking activity, and inhibit neutrophil aggregation, which in turn may result in anti-inflammatory activity

    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

    For the relief of signs and symptoms of Allergy & Cold Symptoms

    Other information

    Take with food or milk if stomach upset occurs

    Hypersensitivity

    History of induce asthma or urticaria with NSAIDs

    Immediately before or after heart surgery

    Within 2 weeks of MAO inhibitor therapy

    GI upset

    Insomnia

    Hemolytic anemia

    Aplastic anemia

    Arrhythmia

    Bronchospasm

    CHF

    Efoliative dermatitis

    Constipation

    Hypertension

    Neutropenia

    Thromboembolism

    Abdominal pain

    Anxiety

    CNS stimulation

    Hepatotoxicity

    Dizziness

    Caution with hypertension, heart disease, hepatic or renal impairment, asthma, thyroid disease, diabetes, or BPH

    Ibuprofen

    • There are no adequate and well-controlled studies in pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive

    Phenylephrine

    • Data from randomized controlled trials and meta-analyses with use in pregnant women during caesarean section have not established a drug-associated risk of major birth defects and miscarriage
    • These studies have not identified an adverse effect on maternal outcomes or infant Apgar scores
    • There are no data on the use during the first or second trimester

    Lactation

    Ibuprofen No lactation studies have been conducted.

    Phenylephrine

    • No data available on the presence of phenylephrine injection or its metabolite in human or animal milk, the effects on the breastfed infant, or the effects on milk production

    Adults

    1 tab PO q4hr PRN while symptoms persist

    Not to exceed 6 tablets/24 hr

    Pediatric

    <12 years: Safety and efficacy not established

    >12 years: 1 tab PO q4hr PRN while symptoms persist; not to exceed 6 tablets/24 hr

    Ibuprofen/phenylephrine

    Tablet

    • 200mg/10mg