Oxymorphone hydrochloride 20 mg
1 INDICATIONS & USAGE Oxymorphone hydrochloride extended-release tablets are indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. Limitations of Usage Oxymorphone hydrochloride extended-release tablets are not intended for use: As an as-needed (prn) analgesic For pain that is mild or not expected to persist for an extended period of time For acute pain For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Oxymorphone hydrochloride extended-release tablets are an opioid agonist indicated for the relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time. ( 1 ) Limitations of Use Oxymorphone hydrochloride extended-release tablets are not for use: As an as-needed (prn) analgesic ( 1 ) For pain that is mild or not expected to persist for an extended period of time ( 1 ) For acute pain ( 1 ) For postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time ( 1 )
Actavis Elizabeth LLC
ROUND BROWN logo 229
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16 HOW SUPPLIED STORAGE AND HANDLING Oxymorphone hydrochloride extended-release tablets are supplied as follows: 5 mg Light pink, round tablets, debossed with “ ” on one side and “227” on the other side. Bottles of 60 with a child-resistant closure…..……….NDC 0228-3227-06 Bottles of 100 with a child-resistant closure………….NDC 0228-3227-11 Bottles of 500 without a child-resistant closure............NDC 0228-3227-50 7.5 mg gray, round tablets, debossed with “ ” on one side and “261” on the other side. Bottles of 60 with a child-resistant closure…..……….NDC 0228-3261-06 Bottles of 100 with a child-resistant closure………….NDC 0228-3261-11 Bottles of 500 without a child-resistant closure............NDC 0228-3261-50 10 mg orange, round tablets, debossed with “ ” on one side and “228” on the other side. Bottles of 60 with a child-resistant closure………..….NDC 0228-3228-06 Bottles of 100 with a child-resistant closure………….NDC 0228-3228-11 Bottles of 500 without a child-resistant closure............NDC 0228-3228-50 15 mg white to off-white, round tablets, debossed with “ ” on one side and “262” on the other side. Bottles of 60 with a child-resistant closure...................NDC 0228-3262-06 Bottles of 100 with a child-resistant closure………….NDC 0228-3262-11 Bottles of 500 without a child-resistant closure............NDC 0228-3262-50 20 mg Light tan to tan, round tablets, debossed with “ ” on one side and “229” on the other side. Bottles of 60 with a child-resistant closure...................NDC 0228-3229-06 Bottles of 100 with a child-resistant closure………….NDC 0228-3229-11 Bottles of 500 without a child-resistant closure............NDC 0228-3229-50 30 mg pink, round tablets, debossed with “ ” on one side and “263” on the other side. Bottles of 60 with a child-resistant closure...................NDC 0228-3263-06 Bottles of 100 with a child-resistant closure………….NDC 0228-3263-11 Bottles of 500 without a child-resistant closure............NDC 0228-3263-50 40 mg yellow, round tablets, debossed with “ ” on one side and “230” on the other side. Bottles of 60 with a child-resistant closure...................NDC 0228-3230-06 Bottles of 100 with a child-resistant closure………….NDC 0228-3230-11 Bottles of 500 without a child-resistant closure............NDC 0228-3230-50 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required). 73adaa8e-figure-11 73adaa8e-figure-12 73adaa8e-figure-13 73adaa8e-figure-14 73adaa8e-figure-15 73adaa8e-figure-16 73adaa8e-figure-17
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