Acetaminophen 325 MG tramadol hydrochloride 37.5 MG Oral Tablet
1 INDICATIONS AND USAGE Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. 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 and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 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 and acetaminophen tablets should not be used for an extended period of time. Tramadol hydrochloride and acetaminophen tablets are a combination of tramadol hydrochloride, an opioid agonist, and acetaminophen, and are indicated for the management of acute pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use: ( 1 ) Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): 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 and acetaminophen tablets should not be used for an extended period of time.
aurobindo pharma limited
OVAL YELLOW I90
I90 OVAL YELLOW
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Acetaminophen 325 mg tramadol hydrochloride 37.5 mg
aurobindo pharma limited
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16 HOW SUPPLIED/STORAGE AND HANDLING
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN Tablets USP containing 37.5 mg of tramadol hydrochloride USP and 325 mg of acetaminophen USP are light yellow, capsule shaped, biconvex film-coated tablets debossed with “I90” on one side and plain on the other side and are available as follows. Bottles of 30 NDC 65862-922-30 Bottles of 100 NDC 65862-922-01 Bottles of 500 NDC 65862-922-05 Bottles of 1,000 NDC 65862-922-99 10 x 10 Unit-dose Tablets NDC 65862-922-78 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Store
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablets USP securely and dispose of properly [see Patient Counseling Information (17) ] .
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