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IBUPROFEN DAYTIME, IBUPROFEN NIGHTTIME is a brand name for Ibuprofen, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Studies of Ibuprofen and Diphenhydramine in Combination In a 10-day maximum use safety and efficacy study (AE-97-08), a total of 1016 patients between 12 to >65 years of age took either one Ibuprofen and Diphenhydramine Hydrochloride Capsules (ibuprofen 200 mg/diphenhydramine HCl 25 mg) (n= 158), or two Ibuprofen and Diphenhydramine Hydrochloride Capsules (ibuprofen 400 mg/diphenhydramine HCl 50 mg) (n=323), or two Tylenol PM caplets (acetaminophen 1000 mg/diphenhydramine HCl 50 mg) (n=326) or a placebo (N=167) for 10 consecutive evenings.
They were instructed to begin taking the study drug on the first evening they experienced sleeplessness associated with a headache or minor aches or pains. They continued to take study medication for the next 9 consecutive evenings, regardless of whether or not they were experiencing symptoms.
Although the duration of use was beyond the maximum over-the-counter duration of use (10 days versus 5 days) of ibuprofen, the daily dose was below the maximum daily dose for ibuprofen of 1200 mg and for diphenhydramine of 150 mg. S.
marketed analgesic/sleep-aid product consisting of acetaminophen 1000 mg/diphenhydramine hydrochloride 50 mg. The incidences of these symptoms were similar for both doses of ibuprofen / diphenhydramine (400 mg/50 mg vs. 200 mg/25 mg).
The AEs with incidence rates exceeding 2% in any treatment group are presented in Table 1. 132 Page 13 of 61 Table 1.
AE-97-08:
Adverse Events with Incidence Rates Exceeding 2% in Any Treatment Group Number (%) of Subjects with AE Indicated Body System Placebo (n=167) 1. Ibuprofen and Diphenhydramine Hydrochloride Capsule (n=158) 2. S. 05 are bolded. Two placebo-controlled, double-blind clinical trials (AE-98-01 and AE-98-02) studied subjects 16-45 years of age who had undergone surgical removal of 1 or 2 impacted third molars, one of which was at least a partial bony mandibular impaction, and were given a single dose of either placebo ibuprofen (400mg) /diphenhydramine (50 mg) or 400 mg ibuprofen (n=118), before bedtime on the day of surgery.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Study AE-98-01 involved 281 subjects, with 40 receiving placebo, 122 receiving ibuprofen (400 mg) /diphenhydramine (50 mg) and 118 receiving 400 mg ibuprofen. The active treatments were well tolerated [123]. 9% in the ibuprofen group.
The AEs with incidence rates exceeding 2% in any treatment group are presented in Table 2. 8%). There were no serious AEs. Page 14 of 61 Table 2. 10). Study AE-98-02 involved 283 subjects, with 40 receiving placebo, 120 receiving ibuprofen (400 mg) /diphenhydramine (50 mg) and 123 receiving 400 mg ibuprofen.
124 The AEs with incidence rates exceeding 2% in any treatment group are presented in Table 3. There was a significant difference among the three treatment groups with respect to overall adverse experiences. 0%; […]