{"adverse_reactions":["ADVERSE REACTIONS Tramadol hydrochloride was administered to 550 patients during the double-blind or open-label extension periods in U.S. clinical studies of chronic nonmalignant pain."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY PHARMACODYNAMICS Tramadol Hydrochloride contains tramadol, a centrally acting synthetic opoid analgesic."],"clinical_studies":["CLINICAL STUDIES Tramadol hydrochloride has been given in single oral doses pf 50, 75 and 100 mg to patients with pain following surgical procedures and pain following oral surgery (extraction if impacted molars)."],"contraindications":["CONTRAINDICATIONS Tramadol hydrochloride tablets, USP should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opoids."],"description":["Each capsule contains: Tramadol Hydrochloride, USP ..........50 mg","Usual Dosage: For dosage and other prescribing information, see accompanying insert.","DESCRIPTION Tramadol hydrochloride tablets, USP are a centrally acting analgesic."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults (17 years of age and older) For patients with moderate to moderately severe chronic pain not requiringrapid onset of analgesic effect, the tolerability of tramadol hydrochloride, USP can be improved by initiating therapy with a titration regimen:"],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE . Abuse Tramadol has mu-opoid agonist activity."],"effective_time":"20151016","id":"29f6c282-ded6-4d49-9dc2-f402d4fb76ea","indications_and_usage":["INDICATIONS AND USAGE Tramadol hydrochloride tablets, USP are indicated for the management of moderate to moderately severe pain in adults."],"openfda":{},"overdosage":["OVERDOSAGE Acute overdosage with tramadol can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, seizures, bradycardia, hypotension, cardiac arrest, and death."],"package_label_principal_display_panel":["copy of label"],"precautions":["PRECAUTIONS Acute Abdominal Conditions The administration of tramadol hydrochloride may complicate the clinical assessment of patients with acute abdominal conditions"],"set_id":"baaaa16c-48a8-4d92-83ca-319c091dd931","spl_product_data_elements":["TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TRAMADOL LACTOSE MONOHYDRATE SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYSORBATE 80 TITANIUM DIOXIDE HYPROMELLOSES STARCH, CORN White AN;627"],"storage_and_handling":["Store at 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30 C (59 to 86 F)[See USP Controlled Room Temperature] Dispense in a tight container as defined in the USP. Keep out of reach of children."],"version":"2","warnings":["WARNINGS Seizure Risk Seizures have been reported in patients receiving Tramadol hydrochloride within the recommended dosage range."]}