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COLD + SINUS PLUS 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 PLUS (Ibuprofen, Pseudoephedrine Hydrochloride and Chlorpheniramine Maleate Caplets) is indicated for: • the temporary relief of symptoms associated with the common cold, including nasal congestion, sore throat, headache, fever, minor body aches and pains, rhinorrhea, sneezing, itching of the eyes,…
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 COLD + SINUS PLUS may occasionally produce side effects such as heartburn, constipation, nausea, bloating, dry mouth, 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.
Adverse Events in Studies of Ibuprofen, Pseudoephedrine hydrochloride and Chlorpheniramine maleate caplets One 7-day study of the efficacy and safety of ibuprofen, pseudoephedrine hydrochloride and chlorpheniramine maleate caplets in 1070 subjects with seasonal allergic rhinitis, as well as two single- dose bioavailability studies in a total of 41 healthy subjects was conducted.
Adverse events were infrequent in the two bioavailability studies, with no specific adverse event occurring in more than two subjects after any one treatment. None of the adverse events was severe, and no subjects withdrew from the studies because of adverse events.
The design of the 7-day study is described in Clinical Trials. Subjects were treated with one of the following regimens three times daily for 7 days: (1) placebo, (2) two caplets, each containing 200 mg ibuprofen, 30 mg pseudoephedrine, and 2 mg chlorpheniramine, (3) one caplet containing 200 mg ibuprofen, 30 mg pseudoephedrine, and 2 mg chlorpheniramine, or (4) one tablet containing 30 mg pseudoephedrine and 2 mg chlorpheniramine.
3% in the group taking one tablet of pseudoephedrine/chlorpheniramine (1 x P/C). The 2 x I/P/C group had a significantly higher percentage of subjects reporting adverse events than in any COLD + SINUS PLUS Ibuprofen, Pseudoephedrine Hydrochloride and Chlorpheniramine Maleate Caplets Page 18 of 54 other group, whereas the percentages were similar in the other three groups (Table 2).
, Cardiovascular, Gastrointestinal, Monitoring and Laboratory Tests, Special Populations – Oligohydramnios/Neonatal Renal Impairment, Pregnant Women and Breastfeeding 10/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES .......................................................................................... 2 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............................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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For the three active treatment groups, the percentages of subjects with adverse events classified to the nervous system were significantly higher than in the placebo group. In comparison with the other two active treatment groups, the percentage with nervous system adverse events was significantly higher in the 2 x I/P/C group.
Also contributing to the higher overall percentage of subjects with adverse events in the 2 x I/P/C group was a higher percentage with adverse events classified to body as a whole (Table 2). In contrast, for the body system skin and appendages, adverse events were less frequent in the three active treatment groups than in the placebo group.
For adverse events classified to the digestive system, the rate was lowest in the 1 x I/P/C group and similar among the other three groups (Table 2). That result indicates that the addition of ibuprofen to the combination P/C did not increase the incidence of digestive adverse events.
Table 2. 05. Four of the nine most frequent adverse events were associated with the nervous system (Table 3). The most frequent adverse event was somnolence. Somnolence and dry mouth were significantly more frequent in the three active treatment groups than in the placebo group.
The 2 x I/P/C group had a significantly higher frequency of somnolence than in the other two active treatment groups, which were similar in frequency of somnolence. That finding indicates that the frequency of somnolence was affected by the twofold increase in the dose of chlorpheniramine between the 1 x I/P/C and 2 x I/P/C groups and not by the addition of ibuprofen to the P/C combination.
The second most frequent adverse event was dry mouth (Table 3). The frequency of dry mouth was significantly higher in the three active treatment groups than in the placebo group. 4%). 1%) than in the placebo and 1 x P/C groups (0%). COLD + SINUS PLUS Ibuprofen, Pseudoephedrine Hydrochloride and Chlorpheniramine Maleate Caplets Page 19 of 54 Other differences in frequency of the adverse events listed in Table 3 among treatment groups were not statistically significant.
Table 3. Most Frequent Adverse Events in a 7-Day Study in Subjects with Seasonal Allergic Rhinitis (Study AD-99-02) Adverse Experiences Body System/ COSTART Term Number (%) of Subjects with Specified Adverse Event Placebo (N = 265) 2 x I/P/C (N = 269) 1 x I/P/C (N = 263) 1 x P/C (N = […]
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 9 7 WARNINGS AND PRECAUTIONS ................................................................................. 1 Special Populations ..............................................................................................
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...........................................................................
22 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....................................................................... 29 10 CLINICAL PHARMACOLOGY ......................................................................................
1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics .................................................................................................
33 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 36 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 36 PART II: SCIENTIFIC INFORMATION .....................................................................................
36 13 PHARMACEUTICAL INFORMATION .......................................................................... 36 14 CLINICAL TRIALS ......................................................................................................
1 Clinical Trials by Indication .................................................................................. 3 Comparative Bioavailability Studies .................................................................... 44 15 MICROBIOLOGY ......................................................................................................
47 16 NON-CLINICAL TOXICOLOGY .................................................................................... 47 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................... 49 PATIENT MEDICATION INFORMATION […]