Complete SPL Sections#
DESCRIPTION
DESCRIPTION SECTION
Butalbital, Aspirin, and Caffeine Capsules, USP is supplied in capsule form for oral administration. Each capsule contains the following active ingredients: butalbital, USP . . . . . . . . . . . . . 50 mg aspirin, USP. . . . . . . . . . . . . . . . 325 mg caffeine, USP . . . . . . . . . . . . . . 40 mg Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula: C 11 H 16 N 2 O 3 molecular weight 224.26 Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula: C 9 H 8 O 4 molecular weight 180.16 Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula: C 8 H 10 N 4 O 2 molecular weight 194.19 Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, and talc. Gelatin capsules contain D&C Yellow No. 10, FD&C Green No. 3, and gelatin. The capsules are printed with edible ink containing red iron oxide.
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
Pharmacologically, Butalbital, Aspirin, and Caffeine Capsules, USP combines the analgesic properties of aspirin with the anxiolytic and muscle relaxant properties of butalbital. The clinical effectiveness of butalbital, aspirin, and caffeine capsules in tension headache has been established in double-blind, placebo-controlled, multi-clinic trials. A factorial design study compared butalbital, aspirin, and caffeine capsules with each of its major components. This study demonstrated that each component contributes to the efficacy of butalbital, aspirin, and caffeine capsules in the treatment of the target symptoms of tension headache (headache pain, psychic tension, and muscle contraction in the head, neck, and shoulder region). For each symptom and the symptom complex as a whole, butalbital, aspirin, and caffeine capsules was shown to have significantly superior clinical effects to either component alone.
INDICATIONS
INDICATIONS & USAGE SECTION
Butalbital, Aspirin, and Caffeine Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Butalbital, Aspirin, and Caffeine Capsules, USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Butalbital, Aspirin, and Caffeine Capsules, USP is contraindicated under the following conditions: Hypersensitivity or intolerance to aspirin, caffeine, or butalbital. Patients with a hemorrhagic diathesis (e.g., hemophilia, hypoprothrombinemia, von Willebrand’s disease, the thrombocytopenias, thrombasthenia and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency and severe liver damage). Patients with the syndrome of nasal polyps, angioedema and bronchospastic reactivity to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylactoid reactions have occurred in such patients. Peptic ulcer or other serious gastrointestinal lesions. Patients with porphyria.
WARNINGS
WARNINGS SECTION
Therapeutic doses of aspirin can cause anaphylactic shock and other severe allergic reactions. It should be ascertained if the patient is allergic to aspirin, although a specific history of allergy may be lacking. Significant bleeding can result from aspirin therapy in patients with peptic ulcer or other gastrointestinal lesions, and in patients with bleeding disorders. Aspirin administered preoperatively may prolong the bleeding time. Butalbital is habit-forming and potentially abusable. Consequently, the extended use of Butalbital, Aspirin, and Caffeine Capsules, USP is not recommended. Results from epidemiologic studies indicate an association between aspirin and Reye’s Syndrome. Caution should be used in administering this product to children, including teenagers, with chicken pox or flu.
PRECAUTIONS
PRECAUTIONS SECTION
ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The most frequent adverse reactions are drowsiness and dizziness. Less frequent adverse reactions are lightheadedness and gastrointestinal disturbances including nausea, vomiting, and flatulence. A single incidence of bone marrow suppression has been reported with the use of butalbital, aspirin, and caffeine capsules. Several cases of dermatological reactions including toxic epidermal necrolysis and erythema multiforme have been reported.
DRUG ABUSE AND DEPENDENCE
DRUG ABUSE AND DEPENDENCE SECTION
OVERDOSAGE
OVERDOSAGE SECTION
The toxic effects of acute overdosage of Butalbital, Aspirin, and Caffeine Capsules, USP are attributable mainly to its barbiturate component, and, to a lesser extent, aspirin. Because toxic effects of caffeine occur in very high dosages only, the possibility of significant caffeine toxicity from Butalbital, Aspirin, and Caffeine Capsules, USP overdosage is unlikely.
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
One or 2 capsules every 4 hours. Total daily dose should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
HOW SUPPLIED
HOW SUPPLIED SECTION
Butalbital, Aspirin, and Caffeine Capsules, USP Green cap with a yellow body. Cap is imprinted with “WATSON” in red. Body is imprinted with “3219” in red. Bottles of 30 are supplied with child-resistant closures. Store and Dispense Below 25°C (77°F); tight container. Protect from moisture. Rx only Address medical inquiries to: WATSON Medical Communications P.O. Box 1953 Morristown, NJ 07962-1953 800-272-5525 Watson Laboratories, Inc . Corona, CA 92880 USA Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Revised: June 2009 190110 S0609
PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Butalbital, Aspirin, and Caffeine Capsules, USP NDC 33261-0922-30 30 Capsule Count Bottle Label
