It is a further object of the present invention to provide methods for the symptomatic relief of cough, cold, cold-like and flu symptoms and the discomfort, pain, headache, fever and general malaise associated therewith, by the administration of preselected dosages of the pharmaceutical compositions of the present invention. It is, therefore, a primary object of the present invention to provide pharmaceutical compositions of matter comprising an analgesically effective amount of a non-steroidal anti-inflammatory drug in combination with a non-sedating antihistamine, and optionally one or more active components selected from a decongestant, cough suppressant, expectorant and, further optionally including pharmaceutically acceptable carriers therefor. For example, the antipyretic effectiveness of ibuprofen in comparison to aspirin and to acetaminophen has been studied. In the first study, 17 adult patients with fever of 100° F. In the patients with upper respiratory tract infections antipyretic effect from both treatments began approximately one hour after dosing. More specifically, the applicants herein have found that certain non-steroidal anti-inflammatory agents are ideally suited for use in cough/cold formulations by reason of their enhanced analgesic anti-inflammatory and antipyretic activity and low incidence of untoward side effects, particularly at the optimum dosages provided for in the present invention, compared to aspirin or acetaminophen. et al, "Antipyretic Activity of Ibuprofen (Brufen)", J. Physicians, India (1973) 9-584 describes the results of two randomized, double-blind, parallel studies comparing the antipyretic efficacy of ibuprofen to that of aspirin. Once peak temperature was reached as indicated by cessation of rigors, each patient received either ibuprofen 400 mg (5 patients) or aspirin 600 mg (6 patients).Often this can only be determined after the child is evaluated in person by the physician administering the sedation.When this occurs the sedation team of nurses and doctors will meet with the parent and reschedule the procedure under general anesthesia.
These formulations generally contain in addition to aspirin, acetaminophen or salicylamide, one or more conventional antihistaminics, decongestants, cough suppressants, antitussives and expectorants. In the second study, 11 adult patients with resistant, chronic gonococcal urethritis were inoculated with T. In the second study, where the fever was induced by the vaccine, the temperature response curves were again very similar with the mean maximum fall in temperature occurring at about three hours with both treatments. or more (orally) due to upper respiratory tract infections were given a capsule containing either ibuprofen 200 mg (7 patients) or aspirin 300 mg (10 patients). The temperature curves following both treatments were very similar, with the maximum decrease in temperature being reached 31/2 hours following aspirin 300 mg and 41/2 hours following ibuprofen 200 mg. A report by Busson, M., "A Double Blind Multicentre Comparison of Ibuprofen and Placebo in Colds and Non-specific Headaches", The Boots Company, Ltd. See, for example, Physician's Desk Reference, 35th Edition, (1981); The Merck Index, 9th Edition, Merck and Company, Rahway, N. (1976); and Cutting's Handbook of Pharmacology, 6th Edition, Ed. Of the acetic acid derivatives, presently preferred members include tolmetin sodium, sulindac and indomethacin. The superiority the analgesic properties of various of the non-narcotic analgesics belonging to the non-steroidal anti-inflammatory drug class in comparative studies with placebo, aspirin and acetaminophen in patients with various types of pain including headache, aches and pains associated with colds, dental pain, postpartum pain, musculoskeletal pain, menstrual cramping, and so forth, is well documented in the literature. "Suppression of Post Operative Pain by Prepoperative Administration of Ibuprofen in Comparison to Placebo, Acetaminophen and Acetaminophen Plus Codeine." J. The specific compounds falling within the foregoing definition of the non-steroidal anti-inflammatory drugs for use in the present invention are well known to those skilled in the art and reference may be had to various literature reference sources for their chemical structures, pharmacological activities, side effects, normal dosage ranges, etc. Of the propionic acid derivatives for use herein, ibuprofen, naproxen, flurbiprofen, fenoprofen, ketoprofen, fenbufen, and fluprofen may be mentioned as particularly preferred compounds.