{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred vision, cardiac palpitations, flushing, increased irritability or excitement (especially in children)."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Chlorpheniramine maleate is an alkylamine type antihistamine. This group of antihistamines is among the most active histamine antagonists and is generally effective in relatively low doses. The drugs are not so prone to produce drowsiness and are among the most suitable agents for daytime use: but again, a significant proportion of patients do experience this effect. Phenylephrine hydrochloride is a sympathomimetic which acts predominantly on alpha receptors and has little action on beta receptors. It, therefore, functions as an oral nasal decongestant with minimal CNS stimulation. Methscopolamine nitrate is a quaternary ammonium derivative of scopolamine, which possesses the peripheral actions of the belladonna alkaloids, but does not exhibit the central actions because of its lack of ability to cross the blood-brain barrier. In this formulation, it is used because of its antisecretory effects on the respiratory system."],"contraindications":["CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Also contraindicated in patients with severe hypertension, severe coronary artery disease, patients on MAO inhibitor therapy, patients with narrow angle glaucoma, urinary retention, peptic ulcer, and during an asthmatic attack."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each Dallergy® Extended-Release Tablet contains: Chlorpheniramine Maleate.................................. 4 mg Phenylephrine Hydrochloride .............................. 10 mg Methscopolamlne Nitrate .................................. 1.25 mg In a specially prepared base to provide a prolonged therapeutic effect. Chlorpheniramine maleate is an antihistamine having the chemical name 2-pyridinepropanamine, gamma-(4·chlorophenyl)-N, N-dimethyl-, (Z)-2-butenedioate (1 :1) Phenylephrine hydrochloride is a decongestant having the chemical name Benzenemethanol, 3-hydroxy-alpha-[(methylamino)methyl]-, hydrochloride(R) Methscopolamine is an anticholinergic having the chemical name 3-0xa-9-azoniatricyclo [3.3.1.0' 'J nonane, 7-(3-hydroxy1-oxo-2-phenylpropoxy)-9, 9-dimethyi-, nitrate, [7(S)-(1 alpha, 2 beta, 4 beta, 5 alpha, 7 beta)] Dallergy® Tablet contain ingredients of the following therapeutic classes: nasal decongestant, antihistamine, and antisecretory agent."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children 12 years of age and older, one Dallergy - Tablet every 12 hours. Children 6 to under 12 years, one·half tablet every 12 hours. Not to exceed 2 doses in 24 hours. Not recommended for children under 6 years of age. Tablets may be broken in half for ease of administration without affecting release of medication but should not be crushed or chewed prior to swallowing."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Controlled Substance Abuse Dependence"],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions"],"drug_interactions":["Interactions Drug Interactions MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetcs may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Concomitant use of antihistamines with alcohol and other CNS depressants may have an additive effect. Drug/Laboratory Test Interactions","Drug Interactions MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetcs may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Concomitant use of antihistamines with alcohol and other CNS depressants may have an additive effect."],"effective_time":"20110311","general_precautions":["General Caution should be exercised in patients with high blood pressure, heart disease, diabetes. or thyroid disease. The antihistamines in this product may exhibit additive effects with other CNS depressants, including alcohol."],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED Bottles of 100 (NDC 0277-0160-01) white, scored tablets, debossed “LAS” to the left of the score and “160” to the right. The opposite side of the tablet is plain."],"id":"6cb22487-e980-4813-b940-d8e758393152","indications_and_usage":["INDICATIONS AND USAGE For the relief of upper respiratory symptoms associated with allergies and the common cold, such as; nasal congestion, sinusitis, sneezing, lacrimation, vasomotor rhinitis, post-nasal drip, and hay fever."],"information_for_patients":["Information for Patients Antihistamine may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly."],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dallergy® Tablets are administered to a nursing mother."],"openfda":{},"overdosage":["OVERDOSAGE In all cases of suspected overdose, immediately call your regional poison control center, and/or contact a physician immediately. The stomach should be emptied promptly by lavage or by induction of emesis with Syrup of Ipecac. The installation of activated charcoal into the stomach also should be considered. The treatment of overdose is essentially symptomatic and supportive. If respiratory depression is present, treat promptly with oxygen and/or mechanical support of ventilation. If convulsions or marked CNS excitement occurs, only short-acting benzodiazepine-type drugs should be used."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label 6457 CL"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients under 6 years of age have not been established."],"precautions":["PRECAUTIONS General Caution should be exercised in patients with high blood pressure, heart disease, diabetes. or thyroid disease. The antihistamines in this product may exhibit additive effects with other CNS depressants, including alcohol. Information for Patients Antihistamine may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly. Laboratory Tests Interactions Drug Interactions MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetcs may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Concomitant use of antihistamines with alcohol and other CNS depressants may have an additive effect. Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Category C : It is not known whether Dallergy ® Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dallergy ® Tablets should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dallergy® Tablets are administered to a nursing mother. Pediatric Use Safety and effectiveness in pediatric patients under 6 years of age have not been established. Geriatric Use"],"pregnancy":["Pregnancy Category C : It is not known whether Dallergy ® Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dallergy ® Tablets should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"6cb22487-e980-4813-b940-d8e758393152","spl_product_data_elements":["DALLERGY Chlorpheniramine, Phenylephrine, Methscopolamine CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE METHSCOPOLAMINE NITRATE METHSCOPOLAMINE CELLULOSE, MICROCRYSTALLINE WHEY CALCIUM STEARATE LAS;160"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy. The elderly (60 years or older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur."]}