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akorn - butorphanol tartrate (unii: 2l7i72ruhn) (butorphanol - unii:qv897jc36d) - butorphanol tartrate 10 mg in 1 ml - butorphic (butorphanol tartrate injection) is indicated for the relief of pain associated with colic in adult horses and yearlings. clinical studies in the horse have shown that butorphanol tartrate alleviates abdominal pain, associated with torsion, impaction, intussusception, spasmodic and tympanic colic, and postpartum pain.

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merck sharp & dohme corp. - butorphanol tartrate (unii: 2l7i72ruhn) (butorphanol - unii:qv897jc36d) - butorphanol 10 mg in 1 ml - dolorex (butorphanol tartrate) is indicated for the relief of pain associated with colic in adult horses and yearlings. clinical studies in the horse have shown that butorphanol tartrate alleviates abdominal pain associated with torsion, impaction, intussusception, spasmodic and tympanic colic, and postpartum pain.

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avanir pharmaceuticals, inc. - dextromethorphan hydrobromide (unii: 9d2rti9kyh) (dextromethorphan - unii:7355x3rots), quinidine sulfate (unii: j13s2394he) (quinidine - unii:itx08688jl) - dextromethorphan hydrobromide 20 mg - nuedexta is indicated for the treatment of pseudobulbar affect (pba). pba occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. pba episodes typically occur out of proportion or incongruent to the underlying emotional state. pba is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury. nuedexta contains quinidine, and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine. nuedexta is contraindicated in patients with a history of nuedexta, quinine, mefloquine or quinidine-induced thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome. nuedexta is also contraindicated in patients with a known hypersensitivity to dextromethorphan (e.g. rash, hives) [ see warnings and precautions ( 5.1 ) ] . nuedexta is contraindicated in patients taking monoamine oxidase inhibitors (maois) or in patients who have taken maois within the preceding 14 days, due to the risk of serious and possibly fatal drug interactions, including serotonin syndrome. allow at least 14 days after stopping nuedexta before starting an maoi [ see drug interactions ( 7.1 ) ] . nuedexta is contraindicated in patients with a prolonged qt interval, congenital long qt syndrome or a history suggestive of torsades de pointes,  and  in patients with heart failure [ see warnings and precautions ( 5.3 ) ] . nuedexta is contraindicated in patients receiving drugs that both prolong qt interval and are metabolized by cyp2d6 (e.g., thioridazine and pimozide), as effects on qt interval may be increased [ see drug interactions ( 7.2 ) ] .  nuedexta is contraindicated in patients with complete atrioventricular (av) block without implanted pacemakers, or in patients who are at high risk of complete av block. risk summary there are no adequate data on the developmental risk associated with the use of nuedexta in pregnant women. in oral studies conducted in rats and rabbits, a combination of dextromethorphan/quinidine demonstrated developmental toxicity, including teratogenicity (rabbits) and embryolethality, when given to pregnant animals (see data) . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown.  data animal data when dextromethorphan/quinidine was administered orally (0/0, 5/100, 15/100, and 50/100 mg/kg/day) to pregnant rats during the period of organogenesis, embryo-fetal deaths were observed at the highest dose tested and reduced skeletal ossification was observed at all doses. the lowest dose tested (5/100 mg/kg/day) is approximately 1/50 times the recommended human dose (rhd) of 40/20 mg/day on a mg/m2 basis. oral administration to pregnant rabbits during organogenesis in two separate studies (0/0, 5/60, 15/60, and 30/60 mg/kg/day; 0/0, 5/100, 15/100, and 50/100 mg/kg/day) resulted in an increased incidence of fetal malformations at all but the lowest dose tested. the no-effect dose (5/100 mg/kg/day) is approximately 2/100 times the rhd on a mg/m2 basis. when dextromethorphan/quinidine was orally administered to female rats during pregnancy and lactation in two separate studies (0/0, 5/100, 15/100, and 30/100 mg/kg/day; 0/0, 5/100, 15/100, and 50/100 mg/kg/day), pup survival and pup weight were decreased at all doses, and developmental delay was observed in offspring at the mid and high doses. a no-effect dose for adverse developmental effects was not identified. the lowest dose tested (5/100 mg/kg/day) is approximately 1/50 times the rhd on a mg/m2 basis. when dextromethorphan/quinidine was orally administered (0/0, 5/50, 15/50, 25/50 mg/kg) to male and female rats on postnatal day (pnd) 7, the highest dose resulted in neuronal death in brain (thalamus and medulla oblongata). pnd 7 in rat corresponds to the third trimester of the gestation through the first several months of life but may extend to approximately three years of age in humans. risk summary       quinidine is excreted in human milk. it is not known whether dextromethorphan is excreted in human milk. there are no data on the effects of quinidine or dextromethorphan on the breastfed infant or the effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for nuedexta and any potential adverse effects on the breastfed infant from nuedexta or from the underlying material condition. the safety and effectiveness in pediatric patients below the age of 18 have not been established. of the total number of patients with pba in clinical studies of nuedexta, 14 percent were 65 years old and over, while 2 percent were 75 and over. clinical studies of nuedexta did not include sufficient number of patients aged 65 and over to determine whether they respond differently than younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. dose adjustment of nuedexta is not required in patients with mild to moderate renal impairment [ see   clinical pharmacology ( 12.3 )] . the pharmacokinetics of nuedexta have not been evaluated in patients with severe renal impairment; however, increases in dextromethorphan and/or quinidine levels are likely to be observed. dose adjustment of nuedexta is not required in patients with mild to moderate hepatic impairment. the pharmacokinetics of nuedexta have not been evaluated in patients with severe hepatic impairment; however, increases in dextromethorphan and/or quinidine levels are likely to be observed. nuedexta is a low-affinity uncompetitive nmda antagonist and sigma-1 receptor agonist that has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence. however, nuedexta is a combination product containing dextromethorphan and quinidine, and cases of dextromethorphan abuse have been reported, predominantly in adolescents. while clinical trials did not reveal drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this experience the extent to which nuedexta will be misused, diverted, and/or abused once marketed. therefore, patients with a history of drug abuse should be observed closely for signs of nuedexta misuse or abuse (e.g. development of tolerance, increases in dose, drug-seeking behavior). 

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yichang humanwell pharmaceutical co. ltd. - dextromethorphan hydrobromide (unii: 9d2rti9kyh) (dextromethorphan - unii:7355x3rots), guaifenesin (unii: 495w7451vq) (guaifenesin - unii:495w7451vq) - dextromethorphan hydrobromide 20 mg - ■temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold ■helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus ■helps make coughs more productive.

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unit dose services - dextromethorphan hydrobromide (unii: 9d2rti9kyh) (dextromethorphan - unii:7355x3rots) - dextromethorphan hydrobromide 15 mg in 5 ml - promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (maoi) (see precautions, drug interactions ). 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 are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. according to the who expert committee on drug dependence, dextromethorphan could produce very slight psychic dependence but no physical dependence.

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zoetis inc. - butorphanol tartrate (unii: 2l7i72ruhn) (butorphanol - unii:qv897jc36d) - butorphanol tartrate 10 mg - torbutrol is indicated for the relief of chronic non-productive cough associated with tracheobronchitis, tracheitis, tonsillitis, laryngitis and pharyngitis originating from inflammatory conditions of the upper respiratory tract. 1. the safety of torbutrol has not been determined in dogs afflicted with heartworm disease (dirofilaria immitis). 2. torbutrol should not be used in dogs with a history of liver disease. 3. since torbutrol can be effective in totally suppressing cough, it should not be used in conditions of the lower respiratory tract      associated with copious mucus production.

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aurohealth llc - dextromethorphan hydrobromide (unii: 9d2rti9kyh) (dextromethorphan - unii:7355x3rots), doxylamine succinate (unii: v9bi9b5yi2) (doxylamine - unii:95qb77jkpl) - dextromethorphan hydrobromide 30 mg in 30 ml - active ingredients (in each 30 ml dose cup)                           purpose  dextromethorphan hbr usp 30 mg ............................................. cough suppressant doxylamine succinate usp 12.5 mg .............................................. antihistamine temporarily relieves cold symptoms: - cough - runny nose and sneezing - if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinson’s disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. - to make a child sleep - glaucoma - excessive phlegm (mucus) - a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema - trouble urinating due to enlarged prostate gland - a sodium-restricted diet taking sedatives or tranquilizers. - cough lasts more than 7 days, comes back, or occurs with f

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atlantic biologicals corps - dextromethorphan (unii: 7355x3rots) (dextromethorphan - unii:7355x3rots) - dextromethorphan hydrobromide 30 mg in 5 ml - cough suppressant temporarily relieves - cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants - the impulse to cough to help you get to sleep

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rb health (us) llc - dextromethorphan (unii: 7355x3rots) (dextromethorphan - unii:7355x3rots) - dextromethorphan hydrobromide 30 mg in 5 ml - cough suppressant temporarily relieves - cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants - the impulse to cough to help you get to sleep

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melaleuca, inc. - dextromethorphan hydrobromide (unii: 9d2rti9kyh) (dextromethorphan - unii:7355x3rots), guaifenesin (unii: 495w7451vq) (guaifenesin - unii:495w7451vq) - dextromethorphan hydrobromide 10 mg in 5 ml - purpose dextromethorphan hbr, usp 10 mg..........cough suppressant guaifenesin, usp 100 mg............................expectorant uses - temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold - helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistent headache. a persistent cough may be a sign of a serious condition.