{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS The following adverse reactions have been reported for each of the individual components or combinations of ingredients. Acetaminophen -urticaria, epigastric distress, dizziness, palpitations, allergic reactions, rash, thrombocytopenia, and agranulocytosis. Salicylamide -dose-related GI and CNS disturbances are the most common adverse effects of salicylamide. GI disturbances may include nausea, vomiting, heartburn, anorexia, or diarrhea. CNS disturbances may include dizziness, drowsiness, lightheadedness, faintness, or headache. Flushing, hyperventilation, sweating, dry mouth, rash, thrombocytopenia purpura, and mild Salicylism have also been reported. Adverse GI and CNS effects occur infrequently with salicylamide doses of 325-650 mg but occur often with higher doses. Tinnitus, ecchymoses, hemorrhagic lesions, leukopenia, or thrombocytopenia may also occur with high doses. Phenyltoloxamine Citrate -urticaria, drowsiness, disturbed coordination, inability to concentrate, dizziness, insomnia, tremors, nervousness, palpitation, convulsions, muscular weakness, gastric distress, diarrhea, intestinal cramps, blurred Vision, hypotension, urinary retention, dryness of mouth, throat and nose, xerostomia and nausea. Caffeine· cardiac stimulation, irritability, tremor, dependence, nephrotoxity and hyperglycemia."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Durabac Capsules are designed to combine the analgesic, antipyretic properties of acetaminophen and salicylamide with mild antihistamine properties of phenyltoloxamine citrate. The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing. Acetaminophen is rapidly and completely absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion af metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. Salicylamide is the amide of salicylic acid but it is not metabolized to salicylate and does not show cross sensitivity reactions with salicylate compounds. Consequently, it may be administered to patients hypersensitive to aspirin and other salicylates. In addition to analgesic action, salicylamide is also categorized as an antipyretic and antirheumatic agent. Salicylamide is rapidly and almost completely absorbed from the GI tract following oral administration and therefore promotes an initial, rapid relief from pain or fever. It has not been established whether salicylamide has anti-inflammatory effects. In animals the drug produces hypotensive effects, possibly by dilating peripheral blood vessels, and depresses the CNS. Phenyltoloxamine citrate belongs to the ethanolamine chemical class of antihistamines. It acts by competing with histamine for H1 histamine receptor sites, thereby preventing the action of histamine on the cell. Clinically, phenyltoloxamine citrate suppresses the histamine-mediated symptoms of allergic rhinitis, relieving sneezing, rhinorrhea, and itching of the eyes, nose, and throat. Caffeine, like most xanthines, is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk. Caffeine has analgesic properties but also has side-effects such as anxiety, nervousness, nausea, and palpitations. Caffeine is cleared through metabolism and excretion in the urine. The plasma half-life is about 3 hours. Hepatic biotransformation prior to excretion, results in about equal amounts of 1-methylxanthine and 1-methyluric acid. Of the 70% of the dose recovered in the urine, only 3% is an unchanged drug."],"contraindications":["CONTRAINDICATIONS Durabac Capsules are contraindicated in patients hypersensitive to acetaminophen, salicylates, phenyltoloxamine citrate, or caffeine. Durabac Capsules should not be taken by patients taking medication for blood-clotting or if they have kidney or liver dysfunction."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION DESCRIPTION: Each Durabac Capsule contains: Acetaminophen .................................. 325 mg Salicylamide........................................ 250 mg Phenyltoloxamine Citrate.................... 20 mg Caffeine.............................................. 50 mg Durabac Capsules contain the following inactive ingredients: D&C Red #28, D&C Red #33, D&C Yellow #10, Gelatin, Magnesium Stearate, Talc, and Titanium Dioxide. Acetaminophen, 4'hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder is anon-opiate, nonsalicylate analgesic and antipyretic. It is soluble in boiling water and in 1 N sodium hydroxide; freely soluble in alcohol. Salicylamide, 2-hydroxybenzamide, is an analgesic which occurs as a white, practically odorless, crystalline powder. It is slightly soluble in water and in chloroform; soluble in alcohol and in propylene glycol; freely soluble in ether and in solutions of alkalies. Phenyltoloxamine citrate, N, N-dimethyl-2-(a-phenylo-tolyloxy) ethylamine citrate, is an antihistamine which occurs as crystals from water or methanol. It is soluble in water. Caffeine (1, 3, 7, -trimethylxanthine), a bitter, white crystalline powder or white-glistening needles, is a central nervous system stimulant."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children 12 years and older: 1-2 capsules every 4 hours, not to exceed 8 capsules in 24 hours. Children 6 to 12 years of age: Use only as directed by a physician."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Controlled Substance Abuse Dependence"],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions Acetaminophen may produce false· positive test results for urinary 5-hydroxy-indoleacetic acid."],"drug_interactions":["Interactions Drug Interactions The sedative effects of phenyltoloxamine are additive to the CNS depressant effects of alcohol, hypnotics, sedatives and tranquilizers. Although it has not been established that salicylamide shares all the toxic potentials of salicyiates, the usual precautions of salicylate administration should probably be observed since salicylamide is structurally and pharmacologically related to the salicylates. Durabac Capsules may increase the effects of oral anticoagulants and this may result in abnormal bleeding. Phenobarbital may decrease the effect of acetaminophen by hastening its elimination from the body. Caffeine, may enhance the cardiac inotropic effects of beta-adrenergic stimulating agents. Caffeine may increase the metabolism of other drugs such as phenobarbital and aspirin. Drug/Laboratory Test Interactions Acetaminophen may produce false· positive test results for urinary 5-hydroxy-indoleacetic acid.","Drug Interactions The sedative effects of phenyltoloxamine are additive to the CNS depressant effects of alcohol, hypnotics, sedatives and tranquilizers. Although it has not been established that salicylamide shares all the toxic potentials of salicyiates, the usual precautions of salicylate administration should probably be observed since salicylamide is structurally and pharmacologically related to the salicylates. Durabac Capsules may increase the effects of oral anticoagulants and this may result in abnormal bleeding. Phenobarbital may decrease the effect of acetaminophen by hastening its elimination from the body. Caffeine, may enhance the cardiac inotropic effects of beta-adrenergic stimulating agents. Caffeine may increase the metabolism of other drugs such as phenobarbital and aspirin."],"effective_time":"20110412","general_precautions":["General Patients who have bronchial asthma or are allergic to aspirin, use with caution until sensitivity has been determined."],"geriatric_use":["Geriatric Use Do not exceed a total dose of 8 capsules in 24 hours. This drug may be eliminated more slowly than in younger adults. Prolonged use in excessive doses can cause anemia, liver damage with jaundice, and kidney damage."],"how_supplied":["HOW SUPPLIED Durabac Capsules are available as a red and white capsule imprinted \"PE\" on cap and \"826\" on body in bottles of 100, NDC 66869-826-10 Store at controlled room temperature 15 o -30 o C (59 o -86°F). Dispense in a tight, light-resistant container as defined in USP/NF with a child-resistant closure. WARNING: KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY."],"id":"bcbde0d2-d9b8-4ac6-9147-4527d35a43d1","indications_and_usage":["INDICATIONS AND USAGE Durabac Capsules are indicated for the temporary relief of mild to moderate pain and discomfort due to simple headache; for temporary relief of such pain associated with muscle and joint soreness, spasms, neuralgia, sinusitis, minor menstrual cramps, the common cold or grippe, toothache, and minor aches and pains of rheumatism and arthritis. Helps restore mental allertness or wakefulness when experiencing fatigue or drowsiness."],"information_for_patients":["Information for Patients This product may cause sedation. Patients should be cautioned against engaging in acti'!ities requiring mental alertness, such as driving a car or operating machinery."],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers Acetaminophen is known to be excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother."],"openfda":{},"overdosage":["OVERDOSAGE Acetaminophen: Signs and Symptoms: In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and thrombocytopenia may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours postingestion. In adults hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams. Treatment: The stomach should be emptied promptly by gastric lavage or by induction of emesis with ipecac syrup. If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity. Do not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24·hour intervals. Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration. The toxic dose for adults for acetaminophen is 10 g. Salicylamide: Signs and Symptoms: Mild salicylate toxicity may produce symptoms of dizziness, tinnitis, difficulty in hearing, nausea, vomiting, diarrhea and mental confusion. Treatment: These symptoms will usually disappear after the medication is discontinued and blood levels of the salicylate drops. Phenyltalaxamine Citrate: Signs and Symptoms: Convulsions and hyperyrexia in children sensitive to cerebral stimulation. In adults symptoms of stimulation include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions. Treatment: Symptomatic and supportive. Further gastrointestinal absorption can be limited by gastric lavage, and the subsequent administration of repeated doses of activated charcoal. Caffeine: Signs and Symptoms: Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles. Treatment: Do not induce emesis (vomiting) unless instructed to do so by Poison Control or by a physician, The toxic dose for adults for caffeine is 1g."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 7033 cl"],"pediatric_use":["Pediatric Use Safety and effectiveness of Durabac Capsules in children below the age of 12 have not been established."],"precautions":["PRECAUTIONS General Patients who have bronchial asthma or are allergic to aspirin, use with caution until sensitivity has been determined. Information for Patients This product may cause sedation. Patients should be cautioned against engaging in acti'!ities requiring mental alertness, such as driving a car or operating machinery. Laboratory Tests Interactions Drug Interactions The sedative effects of phenyltoloxamine are additive to the CNS depressant effects of alcohol, hypnotics, sedatives and tranquilizers. Although it has not been established that salicylamide shares all the toxic potentials of salicyiates, the usual precautions of salicylate administration should probably be observed since salicylamide is structurally and pharmacologically related to the salicylates. Durabac Capsules may increase the effects of oral anticoagulants and this may result in abnormal bleeding. Phenobarbital may decrease the effect of acetaminophen by hastening its elimination from the body. Caffeine, may enhance the cardiac inotropic effects of beta-adrenergic stimulating agents. Caffeine may increase the metabolism of other drugs such as phenobarbital and aspirin. Drug/Laboratory Test Interactions Acetaminophen may produce false· positive test results for urinary 5-hydroxy-indoleacetic acid. Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Durabac Capsules. It is also not known whether Durabac Capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Durabac Capsules should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Acetaminophen is known to be excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness of Durabac Capsules in children below the age of 12 have not been established. Geriatric Use Do not exceed a total dose of 8 capsules in 24 hours. This drug may be eliminated more slowly than in younger adults. Prolonged use in excessive doses can cause anemia, liver damage with jaundice, and kidney damage."],"pregnancy":["Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Durabac Capsules. It is also not known whether Durabac Capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Durabac Capsules should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"bcbde0d2-d9b8-4ac6-9147-4527d35a43d1","spl_product_data_elements":["DURABAC SALICYLAMIDE, CAFFEINE, ACETAMINOPHEN, AND PHENYLTOLOXAMINE CITRATE SALICYLAMIDE SALICYLAMIDE CAFFEINE CAFFEINE ACETAMINOPHEN ACETAMINOPHEN PHENYLTOLOXAMINE CITRATE PHENYLTOLOXAMINE TALC CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE RED CAP WHITE BODY PE;826"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS If pain persists for more than 10 days, or if redness is present, consult a physician immediately. Children and teenagers should not use this medication for chicken pox or flu symptoms before a doctor is consulted about Reye syndrome, a rare but serious illness. Acetaminophen in massive overdosage may cause hepatotoxicity in some patients (see OVERDOSAGE). Salicylates should be used with extreme caution in the presence of peptic ulcer or coagulation abnormalities. In rare instances, the use of salicylamide in persons allergic to salicylates can result in life-threatening allergic episodes. Phenyltoloxamine citrate should be used with extreme caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy, or bladder neck obstruction. This compound has an atropine like action and therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, cardiovascular disease, or hypertension. The recommended dose for Durabac Capsules contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat."]}