Adult Dosing

Temporary relief of cold, sinus, and flu symptoms

• 1 tab/cap PO q4-6 hrs while symptoms persist; take 2 tabs/caps PO q4-6 hrs if symptoms do not respond to 1 tab/cap
• Max: 6 tabs or caps/24 hrs

• Use lowest effective dose and shortest effective treatment duration
• Dose should be given with food

Pediatric Dosing

Temporary relief of cold, sinus, and flu symptoms

Children's Motrin Cold, Children's Advil Cold (suspension)

• <24 lb or <2 yrs
• Consult a doctor

• 24-47 lb or 2-5 yrs
• 5 mL PO q6hrs PRN
• Max: 20 mL/24 hrs

• 48-95 lb or 6-11 yrs
• 10 mL PO q6hrs PRN
• Max: 40 mL/24 hrs

• Do not use more than directed
• Measure only with dosing cup provided; do not use with other products
• Use lowest effective dose and shortest effective treatment duration
• Dose should be given with food

Advil Cold & Sinus (tablet and capsule)

• >12 yrs
• 1 tab/cap PO q4-6 hrs while symptoms persist; take 2 tabs/caps PO q4-6 hrs if symptoms do not respond to 1 tab
• Max: 6 tabs or caps/24 hrs

Note:

• Use lowest effective dose and shortest effective treatment duration
• Dose should be given with food

[Outline]

• Adult Dosing
• Pediatric Dosing

• Temporary relief of cold, sinus, and flu symptoms including nasal and sinus congestion, headache, stuffy nose, sore throat, minor aches and pains, and fever

• Hypersensitivity to any of the ingredients of the product
• Use in conjunction with or within 14 days of treatment with a monoamine oxidase inhibitor (MAOI)
• ASA or NSAID-induced asthma or urticaria
• Aspirin triad
• Treatment of peri-operative pain in the setting of CABG surgery
• Coronary artery disease
• Uncontrolled or severe hypertension
• Pregnancy 3rd trimester
• Urinary retention

• N/A

Renal Dose Adjustment

• Ibuprofen
• Renal impairment: Dose adjustments not defined; caution advised

• Pseudoephedrine
• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Ibuprofen
• Hepatic impairment: Dose adjustments not defined; caution advised

• Pseudoephedrine
• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Do not exceed recommended dosage or consume for a longer time than directed
• Therapy should not be used in a child <2 years of age, patients with an allergic reaction to any other pain reliever/fever reducer, before or after heart surgery, and in patients who are receiving monoamine oxidase inhibitors (MAOI)
• Advise patients to consult their physician before using therapy in case of stomach bleeding, history of stomach problems, loss of fluid due to vomiting or diarrhea, high blood pressure, heart disease, liver cirrhosis, kidney disease, thyroid disease, asthma, diabetes or trouble urinating
• Increased risk of heart attack or stroke may occur in patients who have used the therapy for a prolonged time or more than directed
• Discontinue therapy if patient experiences faint, bloody or black stools, stomach pain, worsening of fever/pain or nasal congestion or on lasting more than 3 days; also, discontinue therapy if the patient does not get any relief within first 24 hrs of treatment, redness or swelling is present in the painful area, or if any new symptoms appear
• Therapy may cause severe allergic reactions, especially in people allergic to aspirin; discontinue therapy if any allergic reactions occur
• NSAIDs may cause severe stomach bleeding, especially in patients with stomach ulcers or bleeding problems, consuming 3 or more alcoholic drinks a day, and those receiving concomitant anticoagulant or steroid therapy. Concomitant use of other drugs containing NSAIDs also increases the risk of stomach bleeding
• Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting which may become serious have been observed in patients receiving this therapy

Cautions: Use cautiously in

• Asthma
• Cardiovascular disorder
• Arrhythmias
• CHF
• Cardiac disease risk
• Chronic alcohol use
• Coagulation disorder
• Dehydration
• Diabetes mellitus
• Fluid retention
• History of GI bleed
• Angle-closure glaucoma
• Hepatic impairment
• Hypertension
• Hyperthyroidism
• Prostatic hypertrophy
• Prolonged use
• PUD
• PKU (phenylalanine-containing forms)
• Renal impairment
• Smoking
• Debilitated patients
• Elderly patients

Supplemental Patient Information

• Advise patients to take this drug with food or milk if stomach upset occurs

Pregnancy Category:C

Breastfeeding: Ibuprofen: Is preferred choice as an analgesic or antiinflammatory agent in nursing mothers, because of its low levels in breastmilk, short half-life, and use in infants in doses much higher than those excreted in breastmilk. Pseudoephedrine: Small amounts of pseudoephedrine in breastmilk are unlikely to harm the nursing infant; however, it may cause irritability occasionally. A single dose of pseudoephedrine decreases milk production acutely and repeated use interferes with lactation. Mothers with newborns whose lactation is not well established or mothers who are having difficulties producing sufficient milk should not receive pseudoephedrine. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 2 June 2011).

• CV: MI, stroke, thromboembolism, hypertension, CHF, arrhythmias, elevated BP, palpitations, tachycardia
• CNS: Dizziness, CNS stimulation, drowsiness, insomnia, headache
• PSYCHIATRY: Anxiety
• GI: Nausea, vomiting, GI bleed, GI ulceration/perforation, constipation, dyspepsia, abdominal pain
• GU: Nephrotoxicity, renal papillary necrosis, urinary retention
• HEMA: Hemolytic anemia, aplastic anemia, thrombocytopenia, agranulocytosis, ecchymosis, neutropenia, pancytopenia
• METABOLIC: Fluid retention
• EENT: Tinnitus
• DERM: Exfoliative dermatitis, toxic epidermal necrolysis, pruritus, rash
• RESP: Bronchospasm
• HEPA: Hepatotoxicity, elevated liver transaminases
• HYPERSENSITIVITY: Stevens-Johnson syndrome, anaphylactoid reactions, photosensitivity

Ibuprofen

• NSAID; precise mechanism of action unknown; inhibits cyclooxygenase and reduces prostaglandin synthesis, thereby decreasing inflammation, pain, and fever
• Well absorbed (80% from GI tract)
• Metabolized by liver; CYP450: CYP2C9
• Primarily excreted in urine (<1% unchanged)
• Half life: 2-4 hrs

Pseudoephedrine

• Nasal decongestant; acts on alpha-adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction and reducing nasal congestion. Also, relaxes bronchial smooth muscle by stimulating beta2-adrenergic receptors
• Metabolized by liver
• Renally excreted (55-75% unchanged)
• Half-life: 9-16 hrs (depends on urine pH)

US Trade Name(s)

• Children's Advil Cold
• Advil Cold And Sinus
• Children's Motrin Cold
• SINE-AID IB

US Availability

ibuprofen/pseudoephedrine (generic)

• OTC TABS: 200 mg/30 mg
• OTC SUSP: [100 mg/15 mg]/5 mL

Advil Cold and Sinus (ibuprofen/pseudoephedrine)

• OTC TABS: 200 mg/30 mg
• OTC CAPS: 200 mg/30 mg

Children's Advil Cold, Children's Motrin Cold (ibuprofen/pseudoephedrine)

• OTC SUSP: [100 mg/15 mg]/5 mL

Ibuprohm Cold And Sinus (ibuprofen/pseudoephedrine) (generic)

• OTC TABS: 200 mg/30 mg

SINE-AID IB (ibuprofen/pseudoephedrine)

• OTC TABS: 200 mg/30 mg

Canadian Trade Name(s)

• Advil Cold & Sinus Liqui-Gels
• Advil Cold and Sinus
• Advil Cold and Sinus Daytime
• Children's Advil Cold
• Cold + Sinus
• Motrin Cold & Sinus Pain
• Sudafed Sinus Advance
• Vicks DayQuil Sinus Pressure & Pain Relief with Ibuprofen

Canadian Availability

ibuprofen/pseudoephedrine

• TABS: 200 mg/30 mg

Advil Cold & Sinus Liqui-Gels (ibuprofen/pseudoephedrine)

• CAPS: 200 mg/30 mg

Advil Cold and Sinus, Advil Cold and Sinus Daytime, Cold + Sinus, Motrin Cold & Sinus Pain, Sudafed Sinus Advance, Vicks DayQuil Sinus Pressure & Pain Relief with Ibuprofen (ibuprofen/pseudoephedrine)

• TABS: 200 mg/30 mg

Children's Advil Cold (ibuprofen/pseudoephedrine)

• SUSP: [100 mg/15 mg]/5 mL

UK Trade Name(s)

• Cold and Flu Relief with Ibuprofen
• Lemsip Flu 12Hr
• Nurofen Cold & Flu
• Nurofen Sinus Relief
• Non-Drowsy Sudafed Dual Relief Max
• Sudafed Sinus Pressure and Pain

UK Availability

Cold and Flu Relief with Ibuprofen (ibuprofen/pseudoephedrine)

• TABS: 200 mg/30 mg

Lemsip Flu 12Hr (ibuprofen/pseudoephedrine)

• CAPS: 300 mg/45 mg

Nurofen Cold & Flu, Nurofen Sinus Relief (ibuprofen/pseudoephedrine)

• TABS: 200 mg/30 mg

Non-Drowsy Sudafed Dual Relief Max, Sudafed Sinus Pressure and Pain (ibuprofen/pseudoephedrine)

• TABS: 200 mg/30 mg

Australian Trade Name(s)

• Nurofen Cold and Flu
• Sudafed Sinus + Anti-inflammatory Pain Relief Caplets

Australian Availability

Nurofen Cold and Flu (ibuprofen/pseudoephedrine)

• TABS: 200 mg/30 mg

Sudafed Sinus + Anti-inflammatory Pain Relief Caplets (ibuprofen/pseudoephedrine)

• TABS: 200 mg/30 mg

[Outline]

ENT

Upper Respiratory Combinations

Pulmonary

Upper Respiratory Combinations

• Ibuprofen 200 MG / Pseudoephedrine 30 MG Oral Capsule [Advil Cold and Sinus] (Wyeth Consumer Healthcare)
• Ibuprofen 200 MG / Pseudoephedrine 30 MG Oral Tablet (Amerisource Bergen)
• Ibuprofen 200 MG / Pseudoephedrine 30 MG Oral Tablet (McKesson)
• Ibuprofen 200 MG / Pseudoephedrine 30 MG Oral Tablet [Advil Cold and Sinus] (Pfizer Consumer Healthcare)