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

vernalis therapeutics, inc. - codeine phosphate anhydrous (unii: 2x585m1m3t) (codeine - unii:q830pw7520) - codeine phosphate anhydrous 14.7 mg in 5 ml - tuzistra xr is indicated for the temporary relief of cough 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) ]. 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),use in specific populations (8.4) ]. contraindicated in pediatric patients under 12 years of age [see contraindications (4),use in specific populations (8.4) ]. - contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see contraindications (4), use in specific populations (8.4 ) ].                                                                                                                                                                                                        

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

aytu biopharma, inc. - codeine phosphate anhydrous (unii: 2x585m1m3t) (codeine - unii:q830pw7520), chlorpheniramine maleate (unii: v1q0o9oj9z) (chlorpheniramine - unii:3u6io1965u) - tuzistra xr is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.tuzistra xr is indicated for the temporary relief of cough 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 [ ]. not indicated for pediatric patients under 18 years of age [ see use in specific populations (8.4) ]. not indicated for pediatric patients under 18 years of age [ ]. 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),use in specific populations (8.4) ]. contraindicated in pedi

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

akorn - codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j), promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - codeine phosphate 10 mg in 5 ml - promethazine hcl and codeine phosphate 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 hcl and codeine phosphate oral solution is contraindicated for: promethazine hcl and codeine phosphate oral solution is also contraindicated in patients with: risk summary promethazine hcl and codeine phosphate 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), clinical considerations ]. there are no available data with promethazine hcl and codeine phosphate 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

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 - butalbital, aspirin, caffeine, and codeine phosphate capsules, usp  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, usp 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, usp 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 adeno

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

sun pharmaceutical industries, inc. - codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - codeine phosphate 30 mg - acetaminophen and codeine phosphate tablets, usp 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 [see warnings ], reserve acetaminophen and codeine phosphate tablets, usp for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] controlled substance acetaminophen and codeine phosphate tablets, usp contain codeine. codeine in combination with acetaminophen, is a schedule iii controlled substance. abuse acetaminophen and codeine phosphate tablets, usp contain codeine, a substance with a high potential for abuse similar to other opioids, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. acetaminophen and codeine phosphate tablets, usp can be abused and is subject to misuse, addiction, and criminal diversi

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

par pharmaceutical, 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 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 [see warnings ], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - 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, - have not been tolerated, or are not expected to be tolerated. have not been tolerated, or are not expected to be tolerated. acetaminophen and codeine phosphate tablets are contraindicated for: • all children younger than 12 years of age [see warnings ]. • post-operative management in children younger than 18 years of age following tonsillectomy and/or aden

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

physicians total care, inc. - codeine phosphate (unii: gsl05y1mn6) (codeine - unii:q830pw7520), butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - codeine phosphate 30 mg - butalbital, acetaminophen, caffeine, and codeine phosphate capsules is 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. butalbital, acetaminophen, caffeine, and codeine phosphate capsules 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 codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. psychological dependence, physical dependence,

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

apotheca inc - codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j), promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - codeine phosphate 10 mg in 5 ml - promethazine hydrochloride and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. the combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. codeine sulfate is contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. codeine is contraindicated in patients with a known hypersensitivity to the drug. promethazine 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. promethazine hydrochloride and codeine phosphate syrup is a schedule v controlled substance

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)

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