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

apotheca inc - codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j), promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - codeine phosphate 10 mg in 5 ml - promethazine hydrochloride and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. the combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. codeine sulfate is contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. codeine is contraindicated in patients with a known hypersensitivity to the drug. promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. promethazine hydrochloride and codeine phosphate syrup is a schedule v controlled substance

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 - codeine phosphate hemihydrate, quantity: 30 mg; paracetamol, quantity: 450 mg; doxylamine succinate, quantity: 5 mg - tablet, uncoated - excipient ingredients: sodium starch glycollate; magnesium stearate; purified talc; stearic acid; povidone; pregelatinised maize starch; crospovidone - indications as at 9 june 2020: mersyndol 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)

generic health pty ltd - ibuprofen, quantity: 200 mg; codeine phosphate hemihydrate, quantity: 12.8 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; colloidal anhydrous silica; pregelatinised maize starch; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400 - for temporary relief of strong pain and/or inflammation associated with headache (including migraine and tension headache), period pain, dental pain, back pain, neuralgia, rheumatic and arthritic pain, muscular pain.

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.

Australia - English - 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

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.

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

cipla australia pty ltd - doxylamine succinate, quantity: 5.1 mg; codeine phosphate hemihydrate, quantity: 10 mg; paracetamol, quantity: 500 mg - tablet, uncoated - excipient ingredients: maize starch; povidone; purified talc; magnesium stearate; pregelatinised maize starch; sodium lauryl sulfate; colloidal anhydrous silica; hyprolose; stearic acid - for the temporary relief of acute moderate pain