"Medscape Medical News
August 22, 2015
The US Food and Drug Administration (FDA) has granted tentative approval to expand the label for an extended-release formulation of topiramate (Trokendi XR, Supernus "...
Cephadyn Tablets are 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
Oral: One tablet every four hours as needed. Total daily dosage should not exceed 6 tablets.
Extended and repeated use of this product is not recommended because of the potential for physical dependence.
Cephadyn Tablets (Butalbital and Acetaminophen Tablets) 50 mg/650 mg are supplied in bottles of 100 tablets, NDC 59702-650-01 and in bottles of 500 tablets, NDC 59702-650-50. Each tablet contains butalbital 50 mg (Warning: May be habit-forming) and acetaminophen 650 mg. Tablets are uncoated, blue, capsule-shaped and are debossed “A” score “P” on one side and “110” on the other side.
Protect from light and moisture. Store at controlled room temperature, 15°C to 30°C (59°F to 86°F) [see USP].
Dispense in a tight, light-resistant container with a child-resistant closure.
Manufactured for: Atley Pharmaceuticals, Ashland, VA 23005. Manufactured by: Mikart, Inc. Atlanta, GA 30318. Rev. 09/03This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/30/2016
Additional Cephadyn Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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