Application Nr Approved Date Route Status External Links
ANDA076560 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fioricet With Codeine Is Indicated For The Management Of The Symptom Complex Of Tension (or Muscle Contraction) Headache When Non-Opioid Analgesic 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 Fioricet 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. Fioricet With Codeine Is A Combination Product Of Butalbital, A Barbiturate; Acetaminophen; 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 Analgesic And Alternative Treatments Are Inadequate. ( 1 ) Limitations Of Use Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, Reserve Fioricet 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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 4 Total)

Comments