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 Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

waymade healthcare plc - codeine phosphate - oral tablet - 15mg

Malta - English - Medicines Authority

medichem, s.a. fructuós gelabert 6-8, 08970, sant joan despí, (barcellona), spain - sugammadex - solution for injection - sugammadex 200 mg - all other therapeutic products

Malta - English - Medicines Authority

medichem, s.a. fructuós gelabert 6-8, 08970, sant joan despí, (barcellona), spain - sugammadex - solution for injection - sugammadex 500 mg - all other therapeutic products

Malta - English - Medicines Authority

pharmazac, s.a. 31 naousis str., 104 47, athens,, greece - sugammadex - solution for injection - sugammadex 200 mg - all other therapeutic products

Malta - English - Medicines Authority

pharmazac, s.a. 31 naousis str., 104 47, athens,, greece - sugammadex - solution for injection - sugammadex 500 mg - all other therapeutic products

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

nexgen pharma, inc. - codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j), chlorpheniramine maleate (unii: v1q0o9oj9z) (chlorpheniramine - unii:3u6io1965u) - codeine phosphate 54.3 mg - codeine phosphate and chlorpheniramine maleate is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older. important limitations of use not indicated for pediatric patients under 18 years of age [see use in special population (8.4)] patients with known hypersensitivity to codeine, chlorpheniramine or any of the inactive ingredients of codeine phosphate and chlorpheniramine maleate. persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to codeine. teratogenic effects pregnancy category c there are no adequate and well-controlled studies of codeine phosphate and chlorpheniramine maleate in pregnant women. reproductive toxicity studies have not been conducted with codeine phosphate and chlorpheniramine maleate; however, studies are available with individual active ingredients or related active ingredients. because animal reproduction studies are not always predictive of human response, co

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

lannett company, inc. - codeine sulfate (unii: 11qv9bs0cb) (codeine anhydrous - unii:ux6owy2v7j) - codeine sulfate 15 mg - codeine sulfate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 [ s ee warnings and precautions ( 5.1 ) ] , reserve codeine sulfate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - have not been tolerated, or are not expected to be tolerated. have not been tolerated, or are not expected to be tolerated. - have not provided adequate analgesia, or are not expected to provide adequate analgesia. have not provided adequate analgesia, or are not expected to provide adequate analgesia. codeine sulfate tablets are contraindicated for: - all children younger than 12 years of age [see warnings and precautions ( 5.4 )] . - post-operative management in children younger than 18 years of age following tonsillect

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

physicians total care, inc. - codeine sulfate (unii: 11qv9bs0cb) (codeine - unii:q830pw7520) - codeine sulfate 60 mg - codeine sulfate is an opioid analgesic indicated for the relief of mild to moderately severe pain where the use of an opioid analgesic is appropriate. codeine sulfate is contraindicated in patients with known hypersensitivity to codeine or any components of the product. persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to codeine. codeine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. codeine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. codeine sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus. enter section text here codeine sulfate is an opioid agonist and is a schedule ii controlled substance. codeine sulfate can be abused and is subject to criminal diversion.  drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm. drug addiction is

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

h.j. harkins company, inc. - codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - codeine phosphate 30 mg - acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain. this product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. acetaminophen and codeine phosphate tablets are classified as a schedule iii controlled substance. 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 should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.