{"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. Phenyltoloxamine Citrate - urticaria, drowsiness, disturbed coordination, inhability 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, nephrotoxicity and hyperglycemia."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY 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 prostaglanding 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 of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the gluconide conjugate, with small amounts of other conjugates and unchanged drug. Phenyltoloxamine Citrate belongs to the ethanolamine chemical class of antihistamines. It acts by competing with histamine for H. 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 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-methylxantine and 1-methyluric acid. Of the 70% of the dose that is recover in the urine, only 3% is an unchanged drug."],"contraindications":["CONTRAINDICATIONS Flextra TM Plus Capsules are contraindicated in patients hypersensitive to acetaminophen, phenyltoloxamine citrate, or caffeine. Capsules shoiuld 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 Each Flextra TM Plus Capsule contains: Acetaminophen ............................................ 425 mg Phenyltoloxamine Citrate .............................. 45 mg Caffeine ........................................................ 35 mg Flextra TM Plus Capsules contain the following inactive ingredients: D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Red #40, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Talc, and Titanium Dioxide. Acetaminophen, 4-hydroxyacetanilide, a slightly bitter, white odorless crystallline powder is a nonoplate nonsalicylate analgesic and antipyretic. It is soluble in boiling water and in 1 N sodium hydroxide; freely soluble in alcohol. Phenyltoloxamine citrate, N N-dimethyl-2-(α-phenyl-o-tolyloxy) ethylamine citrate, is an antihistamine which occurs as crystals from water or methanol. It is soluble in water."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children 12 years and older: 1 capsule every 4 hours not to exceed 6 capsules in 24 hours. Not recommended for children under 12 years of age. Do not use for more than 10 days unless directed by 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 product false-positive results for urinary 5-hydrozy indoleacetic acid."],"drug_interactions":["Interactions Drug Interactions The sedative effect of phenyltoloxamine are additive to the CNS depressant effects of alcohol, hypnotics, sedatives and tranquilizers. Flextra TM Plus 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 product false-positive results for urinary 5-hydrozy indoleacetic acid.","Drug Interactions The sedative effect of phenyltoloxamine are additive to the CNS depressant effects of alcohol, hypnotics, sedatives and tranquilizers. Flextra TM Plus 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":"20110315","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 Flextra TM Plus Capsules contain acetaminophen 425 mg. and phenyltoloxamine citrate 45 mg and caffeine 35 mg. and are supplied in an orange capsule imprinted 'FLEXTRA\" in blue ink supplied in bottles of 100 NDC 50991-436-01 Store at controlled room temperature 15 o -30 o C (59 o -86 o 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":"bf784528-154f-4137-bd4d-349dabeba0fc","indications_and_usage":["INDICATIONS AND USAGE Flextra TM Plus 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, neuralgia, sinusitis, minor menstrual cramps, the common cold or grippe, toothache, and minor aches and pains of rheumatism and arthritis. Helps restore mental alertness 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 activities recurring 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 the 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, hypolycemic 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 syrup. If the dose of acetaminophen may have exceeded 140mg/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 initializing treatment. Hepatic ensymes should be obtained initially and repeated at 24 hours intervals. Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration. The toxic dose for adults for acetaminophen is 10g. Phenytoloxamine Citrate: Signs and Symptoms: convulsions and hyperyrexia in children 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 posoning 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 1 g."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 7084 CL"],"pediatric_use":["Pediatric Use Safety and effectiveness of Flextra TM Plus 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 activities recurring mental alertness, such as driving a car or operating machinery. Laboratory Tests Interactions Drug Interactions The sedative effect of phenyltoloxamine are additive to the CNS depressant effects of alcohol, hypnotics, sedatives and tranquilizers. Flextra TM Plus 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 product false-positive results for urinary 5-hydrozy indoleacetic acid. Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Category C. Animal reproduction studies have not been conducted with Flextra TM Plus Capsules. It is also not known whether Flextra TM Plus Capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Flextra TM Plus 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 the account the importance of the drug to the mother. Pediatric Use Safety and effectiveness of Flextra TM Plus 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 Category C. Animal reproduction studies have not been conducted with Flextra TM Plus Capsules. It is also not known whether Flextra TM Plus Capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Flextra TM Plus Capsules should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"bf784528-154f-4137-bd4d-349dabeba0fc","spl_product_data_elements":["FLEXTRA ACETAMINOPHEN, CAFFEINE, PHENYLTOLOXAMINE CAFFEINE CAFFEINE ACETAMINOPHEN ACETAMINOPHEN PHENYLTOLOXAMINE CITRATE PHENYLTOLOXAMINE TALC CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE MEDIUM ORANGE OPAQUE FLEXTRA"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS Caution: If pain persist for more than 10 days, or if redness is present, consult a physical immediately. Acetaminophen in massive overdosage may cause hepatotoxity in some patients. Phenyltoloxamine citrate should be used with extreme caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy, or bladder-neck obstruction. This compkund 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 Flextra TM Plus 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 hearbeat."]}