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COLD + SINUS is a brand name for Ibuprofen, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: COLD + SINUS (Ibuprofen and Pseudoephedrine Hydrochloride Tablets) is indicated for: • the temporary relief of symptoms associated with the common cold, including nasal congestion, sore throat pain, headache, fever, and minor body aches and pains. 1.1 Pediatrics Pediatrics (<12 years of age): No data for COLD + SINUS…
Verbatim from this product's HC label. Tap a section to expand.
). 2 CONTRAINDICATIONS • Active peptic ulcer, a history of recurrent ulceration or active inflammatory disease of the gastrointestinal system, such as ulcerative colitis and Crohn’s disease. • Known or suspected hypersensitivity to ibuprofen or other non-steroidal anti-inflammatory (NSAID) drugs.
Patients who are hypersensitive to this drug or any ingredient in the formulation or component of the container. For a complete listing, see
1 Adverse Reaction Overview Serious adverse reactions occur uncommonly with COLD + SINUS. The most common reactions include heartburn, constipation, nausea, bloating, nervousness or sleeplessness. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Safety Studies of Ibuprofen and Pseudoephedrine Combination In patients with upper respiratory infections treated with either ibuprofen 200 mg plus pseudoephedrine 30 mg (n = 294), acetaminophen 500 mg (n = 296), or placebo (n = 146), the frequency of adverse events (mostly gastrointestinal and CNS symptoms) was similar among the three treatment groups.
COLD + SINUS Page 17 of 42 Ibuprofen and Pseudoephedrine Hydrochloride Tablets In a placebo-controlled, double-blind clinical study of 58 subjects with rhinovirus infection, pseudoephedrine given alone or with ibuprofen was well-tolerated.
Symptoms associated with sympathetic stimulation tended to be more frequent in subjects who were treated with pseudoephedrine (60 mg, either alone or with 200 mg ibuprofen) than in those who received placebo. The three treatment groups were similar in mean pulse rate and mean blood pressure.
5 Post-Market Adverse Reactions Safety Studies of Ibuprofen - adults The results of a double-blind, placebo-controlled study in healthy subjects (N = 1246) representative of a non-prescription analgesic user population indicate that ibuprofen at a dosage of 1200 mg/day for 10 consecutive days is well tolerated.
; Monitoring and Laboratory Tests – Pregnancy; Special Populations 08/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS ............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 4 1 INDICATIONS .............................................................................................................
1 Pediatrics.................................................................................................................. 2 Geriatrics ..................................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................ 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION................................................................................
1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration .........................................................................................................
5 Missed Dose ............................................................................................................. 6 5 OVERDOSAGE............................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 9 7 WARNINGS AND PRECAUTIONS ................................................................................. 1 Special Populations ................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The frequency of gastrointestinal adverse experiences was similar in the placebo and ibuprofen groups (16% with placebo vs. 19% with ibuprofen). The most frequent gastrointestinal adverse experiences (those reported by ≥ 1% of the subjects) were dyspepsia, abdominal pain, nausea, diarrhoea, flatulence, and constipation.
There was no difference between the two groups in the proportion discontinuing treatment because of gastrointestinal adverse events. 4%) had positive occult blood tests: the frequency was comparable for the two treatments. In two multitrial analyses, a meta-analysis, and a literature review, ibuprofen had a low incidence of gastrointestinal drug reactions, comparable with that of acetaminophen and placebo.
In epidemiological studies, ibuprofen has consistently exhibited the lowest relative risk of severe gastrointestinal complications compared with other NSAIDs and acetylsalicylic acid. No symptom or syndrome emerged in the trials that was not predicted from the drug’s pharmacology or could not have been anticipated based on ibuprofen’s extensive use as an analgesic/antipyretic in adults.
Garcia-Rodriguez reported on the frequency of acute liver injury among 625,307 people who received NSAIDs in England and Wales between 1987 and 1991, of whom 311,716 were prescribed ibuprofen. 6/100,000. This was the lowest incidence among the eight NSAIDs studied and was significantly lower than the incidence among users of ketoprofen, piroxicam, fenbrufen, or sulindac.
For NSAID users as a group, the only factors that had an independent effect on the occurrence of acute liver injury were simultaneous use of hepatotoxic medication and the presence of rheumatoid arthritis. Adverse Events with Doses of Ibuprofen ≥ 1200 mg/day Gastrointestinal In clinical trials of NSAIDs, symptomatic upper GI ulcers, gross bleeding, or perforation occurred in approximately 1% of patients treated for 3-6 months and in about 2-4% of patients treated for 1 year.
The risk continues beyond 1 year. The incidence of GI complications increases with increasing dose. Incidence 3-9%: nausea, epigastric pain, heartburn. Incidence 1-3%: diarrhoea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of the gastrointestinal tract (bloating or flatulence).
Incidence <1%: gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal haemorrhage, melena, hepatitis, jaundice, abnormal liver function (SGOT, serum bilirubin and alkaline phosphatase). Allergic COLD + SINUS Page 18 of 42 Ibuprofen and Pseudoephedrine Hydrochloride Tablets Incidence <1%: anaphylaxis (See 2 CONTRAINDICATIONS).
Causal relationship unknown: fever, serum sickness, lupus erythematosus. Central Nervous System Incidence 3-9%: dizziness. Incidence 1-3%: headache, nervousness. Incidence <1%: depression, insomnia. Causal relationship unknown: paraesthesias, hallucinations, abnormal dreams.
Aseptic meningitis and meningoencephalitis, in one case accompanied by eosinophilia in the cerebrospinal fluid, have been reported in patients who took ibuprofen intermittently and did not have any connective tissue disease. Dermatologic Incidence 3-9%: rash (including maculopapular type).
Incidence 1-3%: pruritus. Incidence <1%: vesiculobullous eruptions, urticaria, erythema multiforma. Causal relationship unknown: alopecia, Stevens-Johnson syndrome. Cardiovascular Incidence <1%: congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations.
Causal relationship unknown: arrhythmias (sinus tachycardia, sinus bradycardia, palpitations). Special Senses Incidence 1-3%: tinnitus. Incidence <1%: amblyopia (blurred and/or diminished vision, scotomata, and/or changes in colour vision).
Any patient with eye complaints during ibuprofen therapy should have an ophthalmological examination. Causal relationship unknown: conjunctivitis, diplopia, optic neuritis. Haematologic Incidence <1%: leukopenia, decreases in haemoglobin and haematocrit.
Causal relationship unknown: […]
1 Pregnant Women ............................................................................................. 2 Breast-feeding .................................................................................................. 3 Pediatrics..........................................................................................................
4 Geriatrics .......................................................................................................... 16 8 ADVERSE REACTIONS...............................................................................................
1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................. 5 Post-Market Adverse Reactions.............................................................................
17 9 DRUG INTERACTIONS .............................................................................................. 1 Serious Drug Interactions ......................................................................................
2 Drug Interactions Overview ................................................................................... 3 Drug-Behavioural Interactions ............................................................................... 4 Drug-Drug Interactions ..........................................................................................
5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions.........................................................................
25 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics ..........................................................................................
3 Pharmacokinetics ............................................................................................. 28 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 30 12 SPECIAL HANDLING INSTRUCTIONS..........................................................................
30 PART II: SCIENTIFIC INFORMATION ..................................................................................... 30 13 PHARMACEUTICAL INFORMATION .......................................................................... 30 14 CLINICAL TRIALS ......................................................................................................
1 Clinical Trials by Indication .............................................................................. 3 Comparative Bioavailability Studies ................................................................ 34 15 MICROBIOLOGY ......................................................................................................
36 16 NON-CLINICAL TOXICOLOGY .................................................................................... 36 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................... 37 PATIENT MEDICATION INFORMATION ................................................................................
38 COLD + SINUS Page 4 of 42 Ibuprofen and Pseudoephedrine Hydrochloride Tablets PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS COLD + SINUS (Ibuprofen and Pseudoephedrine Hydrochloride Tablets) is indicated for: […]