Ibuprofen/Phenylephrine

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

Ibuprofen/phenylephrine

Tablet

• 200mg/10mg