Aspirin 325 MG butalbital 50 MG Caffeine 40 MG Codeine Phosphate 30 MG Oral Capsule Ascomp

1 INDICATIONS AND USAGE ASCOMP with CODEINE 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, even at recommended doses [see Warnings and Precautions (5.1)] , reserve ASCOMP with CODEINE 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.

nexgen pharma, inc.

FDA Reported Adverse Reactions
`[1] diarrhoea` `[2] nausea` `[3] off label use` `[4] vomiting` `[5] dyspnoea` `[6] fatigue` `[7] neutropenia` `[8] disease progression` `[9] neuropathy peripheral` `[10] asthenia`

3 years ago

CAPSULE YELLOW B 074

16 HOW SUPPLIED/STORAGE AND HANDLING ASCOMP with CODEINE capsules have a plain blue opaque cap with a yellow opaque body imprinted with "B 074" in black ink. They are available in bottles of 100 capsules [NDC 0722-6094-01] and 500 capsules [NDC 0722-6094-05]. Store and Dispense Below 25°C (77°F); tight container. Protect from moisture. Store ASCOMP with Codeine securely and dispose of properly [see Patient Counseling Information (17)] .

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Aspirin 325 MG butalbital 50 MG Caffeine 40 MG Codeine Phosphate 30 MG Oral Capsule Ascomp

FDA Reported Adverse Reactions [1] diarrhoea [2] nausea [3] off label use [4] vomiting [5] dyspnoea [6] fatigue [7] neutropenia [8] disease progression [9] neuropathy peripheral [10] asthenia

CAPSULE YELLOW B 074

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FDA Reported Adverse Reactions
`[1] diarrhoea` `[2] nausea` `[3] off label use` `[4] vomiting` `[5] dyspnoea` `[6] fatigue` `[7] neutropenia` `[8] disease progression` `[9] neuropathy peripheral` `[10] asthenia`