Store Pharmacy at room temperature away from moisture and heat.
Pharmacy comes as a tablet to take by mouth. It commonly is taken every 4-6 hours as needed. It may be taken with or without food. Follow the instructions on your prescription label carefully, and ask your physician or pharmacist to explain any part you do not understand. Take Pharmacy exactly as ordered. Pharmacy have the potential for physical dependence. Do not take a larger dose take it more often, or for a longer period than your doctor tells you to.
If you think you or someone else may have taken an overdose of Pharmacy, get emergency help at once . Signs of an overdose include convulsions (seizures) and pinpoint pupils of the eyes.
Biovail\'s original application was submitted December 31, 2003 under provisions of Section 505(b)(2) of the Food, Drug and Cosmetic Act. The application included clinical and safety data obtained from four original adequate and well-controlled trials involving more than 3,000 patients who received doses of up to 400mg of Pharmacy ER once daily. The application also included 12 definitive and five supportive pharmacokinetic studies which demonstrated that once-daily dosing of Pharmacy ER delivers the equivalent amount of drug as Ultram(R) (Pharmacy hydrochloride tablets) given three times (TID) or four times (QID) per day.
Pharmacy has been studied in three long-term controlled trials involving a total of 820 patients, with 530 patients receiving Pharmacy. Patients with a variety of chronic painful conditions were studied in double-blind trials of one to three months duration. Average daily doses of approximately 250 mg of Pharmacy in divided doses were generally comparable to five doses of acetaminophen 300 mg with codeine phosphate 30 mg (TYLENOL� with Codeine #3) daily, five doses of aspirin 325 mg with codeine phosphate 30 mg daily, or two to three doses of acetaminophen 500 mg with oxycodone hydrochloride 5 mg (TYLOX�) daily.
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Eligible patients 65 years and older had symptomatic osteoarthritis of the hip or knee for one year or longer, were taking a stable dosage of an NSAID or a cyclooxy-genase-2 inhibitor, and were in general good health. Patients were randomized to receive an initial single dose of one to two pills of Pharmacy/acetaminophen or placebo at the first sign of an osteoarthritis flare. After that, patients could take one to two pills up to four times a day as needed, while continuing their regular NSAID regimen.
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Do not take more of this medication than is prescribed for you. If the pain is not being controlled, talk to your doctor. Taking more than the prescribed amount of this medication could result in seizures or decreased breathing.
Serious potential consequences of overdosage with Pharmacy are central nervous system depression, respiratory depression and death. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment (See OVERDOSAGE).
Do not drink alcohol while taking Pharmacy. Alcohol may cause a dangerous decrease in breathing and/or liver problems when used during treatment with Pharmacy.
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