| Document Date: 2010-11-26 15:04:43
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City Reference / Marietta / / Company LABS INC. / CIMA LABS INC. / Ames / Alaven Pharmaceutical LLC / / Country United States / / Event Product Issues / Product Recall / / Facility Handling Store / / IndustryTerm machinery / food / renal systems / mg/kg oral solution / / MedicalCondition previously detected breast cancer / Diabetic Gastroparesis / Cardiovascular Hypotension / pediatric cancer / trismus / seizures / hallucinations / essential hypertension / cirrhosis / gastroesophageal reflux / Special Populations Renal Insufficiency / dyskinesia / Allergic Reactions A / NADH-cytochrome b5 reductase deficiency / mammary neoplasms / cogwheel rigidity / dystonic reactions resembling tetanus / drowsiness / Gastrointestinal hemorrhage / bradykinesia / muscular rigidity / diarrhea / Neuroleptic Malignant Syndrome / serious movement disorder / Sulfhemoglobinemia / gastroesophageal reflux disease / tiredness / muscle rigidity / hypoglycemia / Ventricular Arrhythmia / asthma / tumor / fatal syndrome / pneumonia / laryngospasm / cancer / Carcinogenesis / metoclopramide-induced methemoglobinemia / neutropenia / undiagnosed pheochromocytoma / AV block / chronic administration / G6PD deficiency / lethargy / Depression Mental depression / vomiting / human breast cancers / involuntary movements / torticollis / Pheochromocytoma / Parkinson’s disease / supraventricular tachycardia / Epilepsy / dizziness / acute and recurrent diabetic gastric stasis / cytotoxic-induced vomiting / Depression / rash / mental depression / tardive dyskinesia / disorders / angioneurotic edema / convulsive seizures / autonomic dysfunction / headaches / laryngeal edema / headache / leukopenia / galactorrhea / nausea / tremor / fatigue / Endocrine Disturbances Galactorrhea / irreversible and disfiguring disorder / both serious medical illness / tachycardia / restlessness / heat stroke / bradycardia / fluid retention / Porphyria / systemic infection / agranulocytosis / Hepatic Insufficiency / gynecomastia / Drug-induced Parkinsonism / Symptomatic Gastroesophageal Reflux / Insomnia / Congestive Heart Failure / acute congestive heart failure / hemolytic anemia / CNS Effects Restlessness / Hypertension / bronchospasm / disease / dyspnea / cardiac arrhythmias / drug-induced movement disorders / Gastrointestinal Nausea / tardive dyskinesia increases / disorientation / Diabetic Gastric Stasis / Renal Insufficiency / concomitant disease / urticaria / advanced liver disease / impotence / Motor restlessness / Methemoglobinemia / syndrome / akathisia / / MedicalTreatment Dialysis / continuous ambulatory peritoneal dialysis / intravenous infusions / chemotherapy / Hemodialysis / drug therapy / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position physician / / Product REGLAN ODT / acetaminophen / cyclosporine / Congestive Heart Failure / diphenhydramine hydrochloride / See Medication / digoxin / period / metoclopramide / Reglan / dantrolene sodium / Benztropine mesylate / Metoclopramide hydrochloride / mannitol / Orally Disintegrating Tablets / patients / tasks / fertility / renal function / / ProvinceOrState Minnesota / Georgia / / PublishedMedium the Medication Guide / / Technology chemotherapy / Dialysis / AV / Pharmacokinetics / DNA synthesis / Pharmacodynamics / / URL www.alavenpharm.com / www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use REGLAN ODT™ safely and effectively. See full prescribing information for REGLAN ODT™ . REGLAN ODT™ (metoclopra