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

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

Ireland - English - HPRA (Health Products Regulatory Authority)

reckitt benckiser ireland ltd - ibuprofen; codeine phosphate hemihydrate - film-coated tablet - 200/12.8 milligram(s) - opioids in combination with non-opioid analgesics; codeine and ibuprofen

Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - ibuprofen; codeine phosphate hemihydrate - film-coated tablet - 200/12.8 milligram(s) - opioids in combination with non-opioid analgesics; codeine and ibuprofen - nsaid - for the relief of pain in such conditions as: rheumatic and muscular pain, backache, migraine, dental pain, dysmenorrhoea, feverishness, symptoms of cold and flu.

Malta - English - Medicines Authority

reckitt benckiser ireland ltd 7 riverwalk citywest business campus dublin 24 , ireland - ibuprofen, codeine phosphate, hemihydrate - film-coated tablet - ibuprofen 200 mg codeine phosphate hemihydrate 12.8 mg - analgesics

Malta - English - Medicines Authority

omega pharma limited 1st floor, 32 vauxhall bridge road, london sw1v 2sa, united kingdom - codeine phosphate, hemihydrate, ibuprofen - film-coated tablet - codeine phosphate hemihydrate 12.8 mg ibuprofen 200 mg - antiinflammatory and antirheumatic products

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 - paracetamol/codeine gh 500/30 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)

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

Malta - English - Medicines Authority

reckitt benckiser ireland ltd 7 riverwalk citywest business campus dublin 24 , ireland - codeine phosphate, hemihydrate, ibuprofen - film-coated tablet - codeine phosphate hemihydrate 12.8 mg ibuprofen 200 mg - analgesics

Malta - English - Medicines Authority

pinewood laboratories limited ballymacarbry, clonmel, co. tipperary, ireland - codeine phosphate - tablet - codeine phosphate 30 mg - analgesics

Malta - English - 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