New Zealand - English - Medsafe (Medicines Safety Authority)

johnson & johnson (new zealand) limited - codeine phosphate hemihydrate 9.5mg equivalent to 7 mg codeine;  ; paracetamol 500mg (from compap l-0093); phenylephrine hydrochloride 5mg equivalent to 4.1 mg phenylephrine;   - tablet - active: codeine phosphate hemihydrate 9.5mg equivalent to 7 mg codeine   paracetamol 500mg (from compap l-0093) phenylephrine hydrochloride 5mg equivalent to 4.1 mg phenylephrine   excipient: colloidal silicon dioxide crospovidone balance of compap l-0093 (as pregelatinised maize starch,stearic acid,povidone,crospovidone)hydrous microcrystalline cellulose opadry white 85f28751 pregelatinised maize starch stearic acid

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.

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)

medreich australia pty ltd - phenylephrine hydrochloride, quantity: 5 mg; paracetamol, quantity: 500 mg; codeine phosphate hemihydrate, quantity: 9.5 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; magnesium stearate; maize starch; microcrystalline cellulose; colloidal anhydrous silica; povidone; crospovidone; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - for the temporary relief from symptoms of colds and flu, including runny nose, nasal congestion, headache and body aches and pains. reduces fever.

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

jerome stevens pharmaceuticals - codeine phosphate (unii: gsl05y1mn6) (codeine - unii:q830pw7520), butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - capsule - 30 mg - butalbital, aspirin, caffeine and codeine phosphate capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. evidence supporting the efficacy of butalbital, aspirin, caffeine and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: 1) butalbital, aspirin, caffeine and codeine; 2) codeine; 3) butalbital, aspirin and caffeine; 4) placebo. response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. the combination product of butalbital, aspirin, caffeine and codeine proved statistically significantly superior to each of its components and to placebo on measures of pain relief. evidence supporting the efficacy and safety of butalbital, aspirin, caffeine and codeine in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because codeine and butalbital are habit

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

sigma company limited - codeine phosphate hemihydrate,paracetamol,phenylephrine hydrochloride -

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

cipla australia pty ltd - paracetamol, quantity: 500 mg; codeine phosphate hemihydrate, quantity: 6 mg; phenylephrine hydrochloride, quantity: 5 mg - tablet, uncoated - excipient ingredients: purified water; magnesium stearate; microcrystalline cellulose; maize starch; colloidal anhydrous silica; hyprolose; povidone - temporary symptomatic relief of headache, myalgia, fever, nasal congestion and rhinorrhoea in patients aged 12 years and older.

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

arrow generics ltd - codeine phosphate - oral tablet - 30mg

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

almus pharmaceuticals ltd - codeine phosphate - oral tablet - 30mg