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

direct_rx - codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - 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 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 adenoidectomy (see warnings). acetaminophen and codeine phosphate tablets are contraindicated in patients with: significant respiratory depression [seewarnings].

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

cipla australia pty ltd - codeine phosphate hemihydrate, quantity: 6 mg; paracetamol, quantity: 500 mg; pseudoephedrine hydrochloride, quantity: 30 mg - tablet, uncoated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; maize starch; sodium starch glycollate; microcrystalline cellulose; povidone - temporary symptomatic relief of rhinorrhoea, nasal congestion, headache, myalgia and fever in patient aged 12 years and over.

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

cipla australia pty ltd - paracetamol, quantity: 500 mg; codeine phosphate hemihydrate, quantity: 15 mg - tablet, uncoated - excipient ingredients: pregelatinised maize starch; maize starch; sodium lauryl sulfate; povidone; purified talc; magnesium stearate; colloidal anhydrous silica; hyprolose; stearic acid - temporary relief of acute moderate pain.

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

medreich australia pty ltd - paracetamol, quantity: 500 mg; codeine phosphate hemihydrate, quantity: 15 mg - tablet, uncoated - excipient ingredients: purified water; povidone; potato starch; ethanol; docusate sodium; magnesium stearate; lactose monohydrate; colloidal anhydrous silica - for temporary relief of acute moderate pain.

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - codeine phosphate hemihydrate 15mg;   - tablet - 15 mg - active: codeine phosphate hemihydrate 15mg   excipient: lactose monohydrate magnesium stearate maize starch microcrystalline cellulose opadry white y-1r-7000b povidone purified water   sodium starch glycolate

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - codeine phosphate hemihydrate 30mg;   - tablet - 30 mg - active: codeine phosphate hemihydrate 30mg   excipient: lactose monohydrate magnesium stearate maize starch microcrystalline cellulose opadry white y-1r-7000b povidone purified water   sodium starch glycolate

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - paracetamol; codeine phosphate hemihydrate; caffeine - effervescent tablet - 500/8/30 milligram(s) - anilides; paracetamol, combinations excl. psycholeptics

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

contract pharmacy services-pa - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 300 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 been tolerated, or are not expected to be tolerated acetaminophen and codeine phosphate tablets are contraindicated in patients with: - patients with significant respiratory depression [see warnings].  - patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings].  - postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy [

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

proficient rx lp - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 300 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] acetaminophen and codeine phosphate tablets are contraindicated in patients with: controlled substance acetaminophen and codeine phosphate tablet contains acetaminophen and codeine phosphate, a schedule cii controlled substance. abuse acetaminophen and codeine phosphate tablet contains  codeine, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydrormorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. acetaminophen and codeine phosphate tablets can be abused and is subject to

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

ncs healthcare of ky, llc dba vangard labs - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 300 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 been tolerated, or are not expected to be tolerated acetaminophen and codeine phosphate tablets are contraindicated in patients with: - patients with significant respiratory depression [see warnings].  - patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings].  - postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy [see warnings]