Aspirin 325 MG butalbital 50 MG Caffeine 40 MG Codeine Phosphate 30 MG Oral Capsule
1 INDICATIONS AND USAGE BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate. BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE is a combination of butalbital, a barbiturate, aspirin, a nonsteroidal anti-inflammatory drug, caffeine, a methylxanthine, and codeine phosphate, an opioid agonist, and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesics and alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids and butalbital, which can occur at any dosage or duration, reserve BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate analgesics) ( 5.1 ): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE 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. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids and butalbital, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 )], reserve BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate 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 BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE 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.
amneal pharmaceuticals ny llc
CAPSULE YELLOW JSP 507
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16 HOW SUPPLIED/STORAGE AND HANDLING Each yellow and blue
BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE capsule USP 50 mg/325 mg/ 40 mg/30 mg is imprinted JSP 507 Bottles of 100 NDC 69238-1993-1 Store and Dispense Below 25°C (77°F); in a tight, light resistant container. Keep out of reach of children
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