Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Butalbital, Aspirin, and Caffeine Capsules, USP White to Off-White powder filled into Capsules, Size 00, Green opaque/White opaque, Black Imprint on cap: 'NB' above '534'. Bottles of 100 are supplied with child-resistant closures. (NDC 69367-416-01) Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature ] Dispense in a tight container as defined in the USP with a child-resistant closure. Protect from moisture.; PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label NDC 69367-416-01 Rx Only Butalbital, Aspirin, and Caffeine Capsules, USP CIII 50 mg/325 mg/40 mg 100 Capsules Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label
- HOW SUPPLIED Butalbital, Aspirin, and Caffeine Capsules, USP White to Off-White powder filled into Capsules, Size 00, Green opaque/White opaque, Black Imprint on cap: 'NB' above '534'. Bottles of 100 are supplied with child-resistant closures. (NDC 69367-416-01) Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature ] Dispense in a tight container as defined in the USP with a child-resistant closure. Protect from moisture.
- PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label NDC 69367-416-01 Rx Only Butalbital, Aspirin, and Caffeine Capsules, USP CIII 50 mg/325 mg/40 mg 100 Capsules Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label
Overview
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: lactose monohydrate, pregelatinized maize starch, sodium starch glycolate and talc. Gelatin capsule contains yellow iron oxide, FD&C Blue # 2, titanium dioxide and gelatin. The imprinting ink contains the following: black iron oxide, D&C Yellow # 10 Aluminum Lake, FD&C Blue #1/ Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/ Indigo Carmine Aluminum Lake, FD&C Red # 40/ Allura Red AC Aluminum Lake, propylene glycol and shellac glaze. Chemical Structure Chemical Structure Chemical Structure
Indications & Usage
INDICATIONS Butalbital, Aspirin, and Caffeine Capsules 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 in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
Dosage & Administration
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.
Warnings & Precautions
WARNINGS 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 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. Fetal Toxicity Premature Closure of Fetal Ductus Arteriosus Avoid use of NSAIDs, including Butalbital, Aspirin, and Caffeine Capsules, in pregnant women at about 30 weeks gestation and later. NSAIDs including Butalbital, Aspirin, and Caffeine Capsules, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs, including Butalbital, Aspirin, and Caffeine Capsules, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some post-marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit Butalbital, Aspirin, and Caffeine Capsules use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if Butalbital, Aspirin, and Caffeine Capsules treatment extends beyond 48 hours. Discontinue Butalbital, Aspirin, and Caffeine Capsules if oligohydramnios occurs and follow up according to clinical practice [ see PRECAUTIONS; Pregnancy ]. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as Butalbital, Aspirin, and Caffeine Capsules. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue Butalbital, Aspirin, and Caffeine Capsules and evaluate the patient immediately.
Contraindications
Butalbital, Aspirin, and Caffeine Capsules 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.
Adverse Reactions
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. To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Drug Interactions
The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors. In patients receiving concomitant corticosteroids and chronic use of aspirin, withdrawal of corticosteroids may result in salicylism because corticosteroids enhance renal clearance of salicylates and their withdrawal is followed by return to normal rates of renal clearance. Butalbital, Aspirin, and Caffeine Capsules may enhance the effects of: Oral anticoagulants, causing bleeding by inhibiting prothrombin formation in the liver and displacing anticoagulants from plasma protein binding sites. Oral antidiabetic agents and insulin, causing hypoglycemia by contributing an additive effect, if dosage of Butalbital, Aspirin, and Caffeine Capsules exceeds maximum recommended daily dosage. 6-mercaptopurine and methotrexate, causing bone marrow toxicity and blood dyscrasias by displacing these drugs from secondary binding sites, and, in the case of methotrexate, also reducing its excretion. Non-steroidal anti-inflammatory agents, increasing the risk of peptic ulceration and bleeding by contributing additive effects. Other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression. Butalbital, Aspirin, and Caffeine Capsules may diminish the effects of: Uricosuric agents such as probenecid and sulfinpyrazone, reducing their effectiveness in the treatment of gout. Aspirin competes with these agents for protein binding sites.
Storage & Handling
Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature ] Dispense in a tight container as defined in the USP with a child-resistant closure. Protect from moisture.
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