{"adverse_reactions":["ADVERSE REACTIONS Incidence of most common adverse reactions in the 2 double-blind, placebo controlled - 5 mg studies (incidence of >3% on cyclobenzaprine hydrochloride 5 mg"],"clinical_pharmacology":["CLINICAL PHARMACOLOG Y Cyclobenzaprine HCl relieves skeletal muscle spasm of local origin without interfering with muscle function. It is ineffective in muscle spasm due to central nervous system disease."],"contraindications":["CONTRAINDICATIONS Hypersensitivity to any component of this product. Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation."],"description":["Each film-coated tablet contains : Cyclobenzaprine Hydrichloride, USP 10 mg","Usual Adult Dosage : See package outsert for dosage information","DESCRIPTION Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21N-HCl and a molecular weight of 311.9."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION For most patients, the recommended dose of cyclobenzaprine hydrochloride tablets, USP is 5 mg three times a day."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when cyclobenzaprine hydrochloride is administered, even though they have not been reported to occur with this drug. Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache and malaise. These are not indicative of addiction."],"effective_time":"20151015","how_supplied":["HOW SUPPLIED Cyclobenzaprine hydrochloride tablets, USP 5 mg are supplied as butterscotch yellow-colored, capsule- shaped, film-coated convex tablets, debossed with \"AN40\" on one side and plain on the other side."],"id":"8ba331d2-7824-4d45-9870-2150fa8c4385","indications_and_usage":["INDICATIONS AND USAGE Cyclobenzaprine hydrochloride tablets,USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful muscoskeletal conditions."],"openfda":{},"overdosage":["OVERDOSAGE Although rare, deaths may occur from overdosage with cyclobenzaprine hydrochloride."],"package_label_principal_display_panel":["copy of label"],"precautions":["PRECAUTIONS General. Because of its atropine - like action, cyclobenzaprine hydrochloride should be sued with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure and in patients taking anticholinergic medication."],"set_id":"ec636fad-9537-4001-a691-c7b4cc2b6a96","spl_product_data_elements":["CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C BLUE NO. 2 FD&C YELLOW NO. 6 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYVINYL ALCOHOL SILICON DIOXIDE TALC TITANIUM DIOXIDE Yellow (Butterscotch) AN41"],"storage_and_handling":["This container is not intended for household use. Dispense contents with a child-resistant closure (as required) and in tight, light-resistant container as defined in the USP. 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]. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN."],"version":"2","warnings":["WARNINGS Serotonin Syndrome. The development of a potentially life-threatening serotonin syndrome has been reported with Cyclobenzaprine hydrochloride when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapimal,, or (MAO) inhibitors."]}