Adult Dosing
Common cold and flu symptoms
- 1 tab [200 mg/10 mg] PO q4 hrs PRN
- Max: 6 tabs [1200 mg/60 mg]/24 hrs
Notes:- Use lowest effective dose and shortest effective treatment duration
- Dose should be given with food or milk
Pediatric Dosing
- Safety and effectiveness in pediatric patients <12 yrs have not been established
Common cold and flu symptoms
- Children >12 yrs
- 1 tab [200 mg/10 mg] PO q4 hrs PRN
- Max: 6 tabs [1200 mg/60 mg]/24 hrs
Notes:- Use lowest effective dose and shortest effective treatment duration
- Dose should be given with food or milk
[Outline]
See Supplemental Patient Information
- Do not exceed recommended dosage or consume for a longer time than directed
- Therapy may cause severe allergic reactions manifested as hives, facial swelling, asthma, shock, erythema, rash, and blisters, particularly in people allergic to aspirin. Discontinue therapy if an allergic reaction occurs
- Avoid use in children <12 years of age, patients with an allergic reaction to any other pain reliever/fever reducer, patients immediately before or after heart surgery, and in those receiving MAOIs
- NSAIDs may cause severe stomach bleeding, especially in patients >60 yrs of age, with stomach ulcers or bleeding problems, consuming 3 or more alcoholic drinks a day during therapy, and those receiving concomitant anticoagulant or steroid therapy. Concomitant use of other drugs containing NSAIDs also increases the risk of stomach bleeding
- Advise patients to consult their physician before using therapy in case of stomach bleeding, history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, thyroid disease, asthma, diabetes or trouble urinating
- Ibuprofen may decrease the therapeutic benefit of aspirin for heart attack or stroke. Instruct patients taking aspirin to consult their physician before therapy use
- Increased risk of heart attack or stroke may be seen in patients using this medication for a prolonged time or in doses more than directed
- Discontinue therapy and promptly consult a physician if patient experiences faint, hematemesis, bloody or black stools, and stomach pain. Also, discontinue therapy if new symptoms occur, redness or swelling is noted in the painful area, pain/nasal congestion gets worse or lasts >7 days, fever gets worse or lasts >3 days, or if nervousness, dizziness or sleeplessness occurs
- Instruct patients to immediately contact a Poison Control Center in case of overdose
Cautions: Use cautiously in
- Hepatic impairment
- Renal impairment
- Hypertension
- Cardiac disease risk
- Cardiovascular disease
- Arrhythmias
- CHF
- Asthma
- Hyperthyroidism
- Dehydration
- Diabetes mellitus
- Fluid retention
- History of GI bleed
- Angle-closure glaucoma
- Enlarged prostate
- PUD
- Heartburn
- Coagulation disorder
- Elderly patients
- Concurrent use of diuretics
- Concomitant use of other products containing phenylephrine or nasal decongestant
- Chronic alcohol use
- Smoking
- Debilitated patients
- PKU (phenylalanine-containing forms)
- Prolonged use
Supplemental Patient Information
- Instruct patients to keep this drug out of reach of children
- Instruct patients to avoid alcoholic beverages during therapy
- Advise women of childbearing potential to stop use of this combination drug if they are pregnant, breastfeeding, or having intention of becoming pregnant
Pregnancy Category:C
Breastfeeding: Ibuprofen is a preferred choice as an analgesic or anti-inflammatory 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. Phenylephrine is unlikely to reach the infant in large amounts, as the oral bioavailability of phenylephrine is only about 40%. However, oral administration of phenylephrine decreases milk production. As no information is available on the use of oral phenylephrine during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 18 August 2011). Manufacturer advises to consult a health professional.
US Trade Name(s)
US Availability
Advil Congestion Relief (ibuprofen/phenylephrine)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
- Lemsip Max All Day Cold & Flu Tablets
- Lemsip Max All Night Cold & Flu Tablets
UK Availability
Lemsip Max All Day Cold & Flu Tablets (ibuprofen/phenylephrine)
Lemsip Max All Night Cold & Flu Tablets (ibuprofen/phenylephrine)
Australian Trade Name(s)
Australian Availability
[Outline]