Mayne Pharma Group announced the availability of Butalbital/Acetaminophen (APAP) 50mg/300mg Capsules indicated for the relief of the symptom of complex tension (or muscle contraction) headache

The product consists of a fixed combination of butalbital, a barbiturate, and APAP, an analgesic. Barbiturates may be habit-forming as tolerance and physical/psychological dependence may occur after prolonged use of high doses. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable.

The label includes a Boxed Warning describing the risk of hepatotoxicity associated with APAP. Most cases of liver injury were associated with APAP doses >4000mg daily and often involved >1 APAP-containing product. 

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The Company was initially approved for the new capsule formulation in December 2017. Butalbital/APAP 50mg/300mg is already available as tablets manufactured by Mayne Pharma Group. The new 50mg/300mg capsules will be supplied in 100-count bottles. 

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