"March 11, 2014 - The U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically "...
Fioricet is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
DOSAGE AND ADMINISTRATION
1 or 2 capsules every 4 hours as needed. Total daily dosage should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
Fioricet 50 mg/300 mg/40 mg
Containing 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a light blue opaque body and a light blue opaque cap. Cap is imprinted twice with “FIORICET” in black and body is imprinted twice with three-head profile in black. The capsules are supplied in bottles of 100 capsules (NDC 52544-080-01).
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Dispense in a tight, light-resistant container.
Manufactured By: Nexgen Pharma, Inc., Irvine, CA 92614. For all medical inquiries contact: WATSON, Medical Communications Parsippany, NJ 07054 800-272-5525. Distributed By: Watson Pharma, Inc., Parsippany, NJ 07054 USA. Revised: Aug 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/4/2016
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