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

galt pharmaceuticals, llc - orphenadrine citrate (unii: x0a40n8i4s) (orphenadrine - unii:al805o9og9), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - norgesic tm (orphenadrine citrate, aspirin and caffeine 25 mg/ 385 mg/ 30 mg) tablets are indicated in: - symptomatic relief of mild to moderate pain of acute musculoskeletal disorders. - the orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. the mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. norgesic tm tablets do not directly relax tense muscles in man. because of the mild anticholinergic effect of orphenadrine, norgesic tm tablets should not be used in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy or obstructions at the bladder neck. norgesic tm tablets are also contraindicated in patients with myasthenia gravis and in patients known to be sensitive to aspirin or caffeine. the drug is contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.

Israel - English - Ministry of Health

taro pharmaceutical industries ltd - caffeine; codeine phosphate; paracetamol - caplets - paracetamol 500 mg; caffeine 30 mg; codeine phosphate 10 mg - paracetamol - paracetamol - for the relief of pain and coughs and for the reduction of fever accompanied by pain.

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

proficient rx lp - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), dihydrocodeine bitartrate (unii: 8lxs95bsa9) (dihydrocodeine - unii:n9i9hdb855) - acetaminophen 320.5 mg - trezix™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsulesare indicated for the relief of moderate to moderately severe pain. dihydrocodeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. this combination product is contraindicated in patients with hypersensitivity to dihydrocodeine, codeine, acetaminophen, caffeine, or any of the inactive components listed above, or any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitative equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus. this combination product is subject to the provisions of the controlled substance act and has been placed in schedule iii. dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused. like other opioid analgesics, dihydrocodeine may produce subjected effects

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

skylar laboratories, llc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), dihydrocodeine bitartrate (unii: 8lxs95bsa9) (dihydrocodeine - unii:n9i9hdb855) - dvorah is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve dvorah for use in patients for whom alternative treatment options [e.g., non-opioid 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 dvorah is contraindicated for: - all children younger than 12 years of age [see warnings and precautions ] - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see warnings and precautions ]. dvorah is also contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in

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

nexgen pharma, inc. - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - butalbital 50 mg - butalbital, acetaminophen, 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, acetaminophen, caffeine, and codeine phosphate capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: butalbital, acetaminophen, caffeine, and codeine phosphate capsules are contraindicated for: butalbital, acetaminophen, caffeine, and codeine phosphate capsules are also contraindicated in patients with: risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.6)] . available data with butalbital, acetaminophen, caffeine, and codeine phosphate capsu

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

vensun pharmaceuticals, 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, 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. butalbital, aspirin and caffeine tablets 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

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)

actavis pharma, inc. - codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j), butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - codeine phosphate 30 mg - fiorinal 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 fiorinal 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 fiorinal with codeine is contraindicated for : • all children younger than 12 years of age [see warnings and precautions (5.4)] • postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see warnings and precautions (5.4)] . fiorinal with codeine is also contraindicated in patients with: • significant r

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

aidarex pharmaceuticals 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)

dispensing solutions, inc. - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), codeine phosphate (unii: gsl05y1mn6) (codeine - unii:q830pw7520) - butalbital 50 mg - 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 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. this combination product is contraindicated under the following conditions: - hypersensitivity or intolerance to acetaminophen, caffeine, butalbital, or codeine. - patients with porphyria. butalbital, acetaminophen, caffeine, and codeine phosphate capsules is controlled by the drug enforcement administration and is classified under schedule iii. codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it sho