Statele Unite ale Americii - engleză - 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,

Statele Unite ale Americii - engleză - 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

Statele Unite ale Americii - engleză - 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 - engleză - 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)

Noua Zeelandă - engleză - Medsafe (Medicines Safety Authority)

viatris limited - codeine phosphate hemihydrate 8mg equivalent to 5.92 mg codeine; paracetamol 500mg;   - tablet - active: codeine phosphate hemihydrate 8mg equivalent to 5.92 mg codeine paracetamol 500mg   excipient: maize starch potassium sorbate povidone purified talc starch stearic acid - for adults and children aged 12 years and above for effective, temporary relief of pain and discomfort associated with: · headache · migraine headache · tension headache · period pain · back pain · muscle pain · arthritis · toothache · dental procedures · neuralgia · cold and flu symptoms in adults only (18 years and older) · sore throat paracetamol + codeine tablets also help reduce fever. paracetamol + codeine is suitable for asthmatics sensitive to aspirin and nsaids.

Irlanda - engleză - HPRA (Health Products Regulatory Authority)

pinewood laboratories ltd - codeine phosphate - oral solution - 15 mg/5ml - each 5 ml contains 15 mg codeine phosphate (equivalent to 11.8 mg codeine). each 5 ml also contains 75 micrograms sunset yellow (e110), 645 mg sorbitol and 0.32 micrograms ethanol. - opium alkaloids and derivatives; codeine - codinex contains codeine and is used to treat a dry or painful cough.

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

neo health (otc) pty ltd - paracetamol, quantity: 500 mg; codeine phosphate hemihydrate, quantity: 8 mg - tablet, uncoated - excipient ingredients: pregelatinised maize starch; povidone; maize starch; magnesium stearate - for the temporary relief of acute moderate pain and fever in patients over the age of 18 years.

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

cipla australia pty ltd - ibuprofen, quantity: 200 mg; codeine phosphate hemihydrate, quantity: 12.8 mg - tablet, film coated - excipient ingredients: lactose monohydrate; purified water; maize starch; glyceryl behenate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 6000 - amcal ibuprofen plus codeine is used for temporary relief of acute moderate pain and inflammation in patients over the age of 12 years.

Australia - engleză - 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.

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

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