Label: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE capsule
- NDC Code(s): 72162-1096-1
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 0527-4094
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: CIII
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 31, 2024
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WARNINGHEPATOTOXICITY - ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF LIVER INJURY ARE ASSOCIATED WITH ...
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DESCRIPTIONButalbital, Acetaminophen and Caffeine Capsules, USP are supplied in capsule form for oral administration. Each capsule contains: Butalbital ................... 50 mg - Acetaminophen ........ 325 ...
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CLINICAL PHARMACOLOGYThis combination drug product is intended as a treatment for tension headache. It consists of a fixed combination of butalbital, acetaminophen and caffeine. The role each component plays in the ...
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INDICATIONS AND USAGEButalbital, acetaminophen and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this ...
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CONTRAINDICATIONSThis product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product. Patients with porphyria.
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WARNINGSButalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended. Hepatotoxicity - Acetaminophen has been associated with cases of acute ...
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PRECAUTIONSGeneral - Butalbital, acetaminophen and caffeine capsules should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment ...
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ADVERSE REACTIONSFrequently Observed: The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated ...
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DRUG ABUSE AND DEPENDENCEAbuse and Dependence - Butalbital: Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of ...
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OVERDOSAGEFollowing an acute overdosage of butalbital, acetaminophen and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the ...
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DOSAGE AND ADMINISTRATIONOne or two capsules every four 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 ...
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HOW SUPPLIEDButalbital, Acetaminophen and Caffeine Capsules, USP containing butalbital 50 mg, acetaminophen 325 mg and caffeine 40 mg, are supplied in bottles of 100 capsules, NDC 72162-1096-1. Capsules are ...
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PRINCIPAL DISPLAY PANELButalbital, Acetaminophen, and Caffeine 50mg/325mg/40mg Capsules
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INGREDIENTS AND APPEARANCEProduct Information