tramadol hydrochloride tablet film coated
1 INDICATIONS AND USAGE Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 )] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated or are not expected to be tolerated. Have not provided adequate analgesia or are not expected to provide adequate analgesia. Tramadol hydrochloride tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Tramadol hydrochloride tablets are an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 5.1 ), reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated or are not expected to be tolerated. ( 1 ) Have not provided adequate analgesia or are not expected to provide adequate analgesia. ( 1 ) Tramadol hydrochloride tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
teva pharmaceuticals usa, inc.
OVAL WHITE 58 TV
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tramadol hydrochloride tablet film coated
teva pharmaceuticals usa, inc.
Tramadol Hydrochloride tramadol hydrochloride 50 MG Oral Tablet
Teva Pharmaceuticals USA Inc
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16 HOW SUPPLIED/STORAGE AND HANDLING
TRAMADOL HYDROCHLORIDE tablets USP, 50 mg, are available as white, film-coated, unscored, oval-shaped tablets, debossed “TV” on one side and debossed “58” on the other side. They are available in bottles of 100 (NDC 0093-0058-01) and 500 (NDC 0093-0058-05). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children. Store
TRAMADOL HYDROCHLORIDE tablets securely and dispose of properly [see Patient Counseling Information ( 17 )] .
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