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

rebel distributors corp - codeine phosphate (unii: gsl05y1mn6) (codeine - unii:q830pw7520), promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - codeine phosphate 10 mg in 5 ml - promethazine with codeine 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 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. the combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. concomitant administration of promethazine products with other respiratory depressants has an association with resp

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

Australia - English - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

noumed pharmaceuticals limited - codeine phosphate hemihydrate 15mg;  ;  ;  ;   - tablet - 15 mg - active: codeine phosphate hemihydrate 15mg         excipient: lactose monohydrate magnesium stearate maize starch - codeine phosphate is indicated for: the relief of mild to moderate pain (including pain associated with terminal illness, post-operative pain and headache), the relief of symptoms of diarrhoea (except diarrhoea caused by poisoning),

New Zealand - English - Medsafe (Medicines Safety Authority)

noumed pharmaceuticals limited - codeine phosphate hemihydrate 30mg;  ;  ;  ;   - tablet - 30 mg - active: codeine phosphate hemihydrate 30mg         excipient: acacia lactose monohydrate magnesium stearate maize starch purified talc - codeine phosphate is indicated for: the relief of mild to moderate pain (including pain associated with terminal illness, post-operative pain and headache), the relief of symptoms of diarrhoea (except diarrhoea caused by poisoning),

New Zealand - English - Medsafe (Medicines Safety Authority)

noumed pharmaceuticals limited - codeine phosphate hemihydrate 60mg;  ;  ;  ;   - tablet - 60 mg - active: codeine phosphate hemihydrate 60mg         excipient: lactose monohydrate magnesium stearate maize starch - codeine phosphate is indicated for: the relief of mild to moderate pain (including pain associated with terminal illness, post-operative pain and headache), the relief of symptoms of diarrhoea (except diarrhoea caused by poisoning),

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - paracetamol, quantity: 500 mg; codeine phosphate hemihydrate, quantity: 30 mg - tablet - excipient ingredients: magnesium stearate; stearic acid; povidone; pregelatinised maize starch - short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

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)

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

Malta - English - Malta Medicines Authority

crescent pharma international limited 260, triq san albert, gzira gzr 1150, malta - codeine phosphate - tablet - codeine phosphate 30 mg - cough and cold preparations