{"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, leucopenia, 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."],"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 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 of 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 es 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 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."],"contraindications":["CONTRAINDICATIONS Ed-Flex Capsules are contraindicated in patients hypersensitive to acetaminophen, salicylamide, or phenyltoloxamine citrate. Capsules should not be taken by patients taking medication for blood-clotting or it they have kidney or liver dysfunction."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each Ed-Flex Capsule contains: Acetaminophen, USP ........................ 300 mg Salicylamide, USP ............................. 200 mg Phenyltoloxamine Citrate .................. 20 mg Ed-Flex Capsules contain the following inactive ingredients: FD&C Blue #1, FD&C Red #40, Gelatin, Microcrystalline Cellulose, Talc, and Titanium Dioxide. Acetaminophen, 4 hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder is a nonopiate, 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 (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: 1 or 2 capsules every 4 hours; maximum daily dose, 8 capsules. Children 8 - 12 years of age: one-half adult dose: maximum daily dose, 4 capsules. 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-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. Ed-Flex 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. Although it has not been established that salicylamide shares all the toxic potentials of salicylates, the usual precautions of salicylate administration should probably be observed since salicylamide is structurally and pharmacologically related to the salicylates. Drug/Laboratory Test Interactions Acetaminophen may product false-positive 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. Ed-Flex 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. Although it has not been established that salicylamide shares all the toxic potentials of salicylates, the usual precautions of salicylate administration should probably be observed since salicylamide is structurally and pharmacologically related to the salicylates."],"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 Ed-Flex Capsules are supplied in a red capsule imprinted \"Ed-Flex\" in white ink. Supplied in bottles of 100; NDC 0485-0066-01. Store at controlled room temperature 15 o -30 o C (59 o -88 o F). Dispense in light, light resistant containers as defined in USP/NF with a child resistant closure."],"id":"5fdd10b4-326f-4780-ae2e-625553ddc47b","indications_and_usage":["INDICATIONS AND USAGE Ed-Flex 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 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 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, hypoglycemic coma and thrombocylopenia 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 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 initializing 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, tinnitus, 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. Phenyltoloxamine Citrate: Signs and Symptoms: Convulsions and hyperpirexia in children sensitive to cerebral stimulation. In adulst symptoms of stimulation include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions. Treatment: Symtomatic and supportive. Further gastrointestinal absorption can be limited by gastric lavage, and the subsequent administration of repeated doses of activated charcoal."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 7066 CL"],"pediatric_use":["Pediatric Use Safety and effectiveness of Ed-Flex 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 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. Ed-Flex 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. Although it has not been established that salicylamide shares all the toxic potentials of salicylates, the usual precautions of salicylate administration should probably be observed since salicylamide is structurally and pharmacologically related to the salicylates. Drug/Laboratory Test Interactions Acetaminophen may product false-positive results for urinary 5-hydroxy indoleacetic acid. Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Category C. Animal reproduction studies have not been conducted with Ed-Flex Capsules. It is also not known whether Ed-Flex Capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ed-Flex 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 Ed-Flex 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 Ed-Flex Capsules. It is also not known whether Ed-Flex Capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ed-Flex Capsules should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"5fdd10b4-326f-4780-ae2e-625553ddc47b","spl_product_data_elements":["ED-FLEX aCETAMINOPHEN, SALICYLAMIDE, PHENYLTOLOXAMINE SALICYLAMIDE SALICYLAMIDE ACETAMINOPHEN ACETAMINOPHEN PHENYLTOLOXAMINE CITRATE PHENYLTOLOXAMINE TALC CELLULOSE, MICROCRYSTALLINE Swedish orange opaque ED;FLEX"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS Caution: If pain persists for more than 10 days, or if redness is present, consult a physical immediately. Children and teenagers should not use this medicine 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. 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."]}