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| Drug Name |
BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE |
| Active Ingredient(s) |
BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE |
Form(s) and
Strength(s) Available |
CAPSULE; ORAL:50MG/325MG/40MG/30MG |
Product Information / Press Release Phrenilin® with Caffeine and Codeine Capsules (butalbital, acetaminophen, caffeine, and codeine phosphate) are supplied in capsule form for oral administration.
Each capsules contains: codeine phosphate, USP 30 mg, butalbital, USP 50 mg, caffeine, USP 40 mg, acetaminophen, USP 325 mg.
INDICATIONS AND USAGE
Phrenilin® with Caffeine and Codeine (butalbital, acetaminophen, caffeine and codeine phosphate capsules) are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of Phrenilin® with Caffeine and Codeine (butalbital, acetaminophen, caffeine and codeine phosphate capsules) in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.
DOSAGE AND ADMINISTRATION
One or 2 capsules every 4 hours. 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.
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