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)

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)

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)

pharmpak, 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 relief of mild to moderately severe pain. codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. this product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. controlled substance: acetaminophen and codeine phosphate tablets are classified as a schedule iii controlled substance.   abuse and dependence: codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. psychological dependence, physical dependence, and tolerance may develop upon repeated administration, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

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)

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

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)

nucare pharmaceuticals, inc. - 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]