United States - English - NLM (National Library of Medicine)

physicians total care, inc. - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), codeine phosphate (unii: gsl05y1mn6) (codeine - unii:q830pw7520) - butalbital 50 mg - butalbital, aspirin, caffeine, and codeine phosphate capsules, usp is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. evidence supporting the efficacy of butalbital, aspirin, caffeine, and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: butalbital, aspirin, caffeine, and codeine phosphate capsules; codeine; butalbital, aspirin, and caffeine capsules, usp; and placebo. response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. butalbital, aspirin, caffeine, and codeine phosphate capsules proved statistically significantly superior to each of its components (butalbital, aspirin, and caffeine capsules, usp and codeine) and to placebo on measures of pain relief. evidence supporting the efficacy and safety of butalbital, aspirin, caffeine, and codeine phosphate capsules, usp in the treatmen

United States - English - NLM (National Library of Medicine)

rebel distributors corp - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - butalbital 50 mg - butalbital, aspirin and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. hypersensitivity to aspirin, caffeine or barbiturates. patients with porphyria. butalbital, aspirin, and caffeine tablets are classified as a schedule iii controlled substance. prolonged use of barbiturates can produce drug dependence, characterized by psychic dependence, and less frequently, physical dependence and tolerance. the abuse liability of butalbital, aspirin, and caffeine tablets are similar to that of other barbiturate-containing drug combinations. caution should be exercised when prescribing medication for patients with a known propensity for taking excessive quantities of drugs, which is not uncommon in patients with chronic tension headache.

United States - English - NLM (National Library of Medicine)

mayne pharma inc. - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - butalbital 50 mg - butalbital, aspirin, caffeine, and codeine phosphate capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate. limitations of use: because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see warnings and precautions (5.1)] , reserve butalbital, aspirin, caffeine, and codeine phosphate capsules for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate analgesics): - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia butalbital, aspirin, caffeine, and codeine phosphate capsules are contraindicated for: - all children younger than 12 years of age [see warnings and precautions (5.5)] - postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see warnings

United States - English - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - butalbital 50 mg - butalbital, aspirin, 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 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. butalbital, aspirin, and caffeine capsules are 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 ul

United States - English - NLM (National Library of Medicine)

lannett company, inc. - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - butalbital 50 mg - butalbital, aspirin, 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 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. butalbital, aspirin, and caffeine capsules are 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. butalbital, aspirin, and caffeine capsules are controlled by the drug enforcement administration and are classified under schedule iii. butalbital barbiturates may be habit-forming: tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. the average daily dose for the barbiturate addict is usually about 1,500 mg. as tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. as this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. the lethal dose of a barbiturate is far less if alcohol is also ingested. major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. one method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

United States - English - NLM (National Library of Medicine)

stat rx usa llc - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - butalbital 50 mg - 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. butalbital, aspirin, and caffeine capsules, usp is contraindicated under the following conditions: - hypersensitivity or intolerance to aspirin, caffeine, or butalbital. 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 a hemorrhagic diathesis (e.g., hemophilia, hypoprothrombinemia, von willebrand’s disease, the thrombocytopenias,

United States - English - NLM (National Library of Medicine)

west-ward pharmaceutical corp - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - butalbital 50 mg - butalbital, aspirin, and caffeine tablets, usp are 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 in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because butalbital is habit-forming and potentially abusable. hypersensitivity to aspirin, caffeine, or barbiturates. patients with porphyria.

United States - English - NLM (National Library of Medicine)

dispensing solutions, inc. - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - butalbital 50 mg - butalbital, aspirin, and caffeine tablets are 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 in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because butalbital is habit-forming and potentially abusable. hypersensitivity to aspirin, caffeine, or barbiturates. patients with porphyria.

United States - English - NLM (National Library of Medicine)

h.j. harkins company - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - butalbital 50 mg - butalbital, aspirin, and caffeine tablets are 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 in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because butalbital is habit-forming and potentially abusable. hypersensitivity to aspirin, caffeine, or barbiturates. patients with porphyria.

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - butalbital 50 mg - ascomp with codeine is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see warnings and precautions (5.1)] , reserve ascomp with codeine for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate analgesics): - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia. ascomp with codeine is contraindicated for: - all children younger than 12 years of age [see warnings and precautions (5.5)] - postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see warnings and precautions (5.5)] . ascomp with codeine is also contraindicated in patients with: - significant respiratory depression [se