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)

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 - 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

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

sanofi-aventis australia pty ltd - paracetamol, quantity: 500 mg; codeine phosphate hemihydrate, quantity: 30 mg - tablet, uncoated - excipient ingredients: potassium sorbate; maize starch; povidone; purified talc; stearic acid; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; pregelatinised maize starch - panadeine forte is indicated for the 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)

ncs healthcare of ky, inc dba vangard labs - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain, severe enough to require an opioid analgesic 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 been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia acetaminophen and codeine phosphate tablets are contraindicated in patients with: - significant respiratory depression [see warnings] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings] codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or aden

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

preferred pharmaceuticals, inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - 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 for: acetaminophen and codeine phosphate tablets are contraindicated in patients with: acetaminophen and codeine phosphate tablets contain codeine. codeine in combination with acetaminophen, a schedule iii controlled substance. acetaminophen and codeine phosphate tablets 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 c

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

arrotex pharmaceuticals pty ltd - paracetamol, quantity: 450 mg; codeine phosphate hemihydrate, quantity: 30 mg; doxylamine succinate, quantity: 5 mg - tablet, uncoated - excipient ingredients: purified talc; microcrystalline cellulose; magnesium stearate; sodium starch glycollate; hypromellose - mevadol forte is indicated for the 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.

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

sandoz pty ltd - codeine phosphate hemihydrate, quantity: 12.8 mg; ibuprofen, quantity: 200 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; colloidal anhydrous silica; croscarmellose sodium; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400 - for the temporary relief of acute moderate pain and inflammation in patients over the age of 12 years (see also contraindications and paediatric use)

Ireland - English - HPRA (Health Products Regulatory Authority)

the boots company plc - ibuprofen; codeine phosphate hemihydrate - film-coated tablet - 200 mg/12.8 milligram(s) - opioids in combination with non-opioid analgesics; codeine and ibuprofen

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

generic health pty ltd - codeine phosphate hemihydrate, quantity: 15 mg; paracetamol, quantity: 500 mg - tablet, uncoated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; lactose monohydrate; docusate sodium; povidone; potato starch - for the relief of acute moderate pain and fever.