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),

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

physicians total care, inc. - dihydrocodeine bitartrate (unii: 8lxs95bsa9) (dihydrocodeine - unii:n9i9hdb855), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - dihydrocodeine bitartrate 32 mg - acetaminophen, caffeine, and dihydrocodeine bitartrate tablets are indicated for the relief of moderate to moderately severe pain. this combination product is contraindicated in persons 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 subjective effects other than analgesia (e.g., euphoria, relaxation), which may contribute to abuse by some patients. psychological dependence, physical dependence, and tolerance may d

Malta - English - Medicines Authority

lcm limited linthwaite laboratories, huddersfield, hd7 5qh, united kingdom - codeine phosphate - oral solution - codeine phosphate 15 mg/5ml - cough and cold preparations

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)

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)

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 - codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j), promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - codeine phosphate 10 mg in 5 ml - promethazine vc with codeine oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, 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 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 vc 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 h

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

sun pharmaceutical industries europe b.v. - codeine phosphate - oral tablet - 15mg