미국 - 영어 - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - promethazine with codeine oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. promethazine with codeine oral solution is contraindicated in pediatric patients less than 12 years of age. (see warnings - ultra- rapid metabolism of codeine and respiratory depression ). promethazine with codeine oral solution is contraindicated for post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. (see warnings - ultra- rapid metabolism of codeine and respiratory depression ). codeine is contraindicated in patients with a known hypersensitivity to the drug. promethazine hydrochloride is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. prom

영국 - 영어 - MHRA (Medicines & Healthcare Products Regulatory Agency)

sun pharma uk ltd - codeine phosphate - oral tablet - 15mg

미국 - 영어 - NLM (National Library of Medicine)

actavis 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 - fioricet 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 fioricet 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 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. fioricet with codeine is contraindicated for: - all children younger than 12 years of age [see warnings and precautions (5.5)] . all children younger than 12 years of age [see warnings and precautions (5.5)] . - post-

미국 - 영어 - NLM (National Library of Medicine)

breckenridge pharmaceutical, 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 - 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

미국 - 영어 - NLM (National Library of Medicine)

preferred pharmaceuticals, inc - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine with codeine oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. important limitations of use promethazine with codeine oral solution is contraindicated for: promethazine with codeine oral solution is also contraindicated in patients with: risk summary promethazine with codeine oral solution is not recommended for use in pregnant women, including during or immediately prior to labor. prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.19) and clinical considerations ]. there are no available data with promethazine with codeine oral solution use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. published studies with codeine have reported inconsistent findings and have important methodological limitations (see data ). there are reports of respiratory depression when codei

미국 - 영어 - NLM (National Library of Medicine)

par pharmaceutical - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine with codeine oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. important limitations of use - not indicated for pediatric patients under 18 years of age [see use in specific populations (8.4) ]. - contraindicated in pediatric patients under 12 years of age [see contraindications (4) and use in specific populations (8.4) ]. - contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy and/or adenoidectomy [see contraindications (4) and use in specific populations (8.4) ]. - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1) ], reserve promethazine with codeine oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. promethazine with c

영국 - 영어 - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - codeine phosphate - oral tablet - 60mg

캐나다 - 영어 - Health Canada

teva canada limited - codeine phosphate - tablet - 15mg - codeine phosphate 15mg - opiate agonists

캐나다 - 영어 - Health Canada

teva canada limited - codeine phosphate - tablet - 30mg - codeine phosphate 30mg - opiate agonists

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - codeine phosphate hemihydrate, quantity: 5 mg/ml - oral liquid, solution - excipient ingredients: glycerol; propylene glycol; sucrose; purified water; potassium sorbate; hydrochloric acid; sodium hydroxide; methyl hydroxybenzoate; propyl hydroxybenzoate; ethyl hydroxybenzoate; butyl hydroxybenzoate; isobutyl hydroxybenzoate - relief of unproductive, dry and intractable coughs associated with colds and flu.