{"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. However, a significant proportion of patients do experience this effect. Phenylephrine HCI is a sympathomimetic amine 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."],"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 asthma attack. Should not be used in children under 12 years of age or in nursing mothers."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Chlorpheniramine maleate ............ 8 mg Phenylephrine hydrochlorie .......... 20 mg In a specially prepared base to provide prolonged action. This product contains ingredients in the following therapeutic classes: antihistamine and decongestant. Chlorpheniramine maleate is an antihistamine having the chemical name: 2-pyridinepropanamine, y-(4-chlorophenyl) N, N-dimethyl-, (Z)-2-butenedioate (1:1). Phenylephrine hydrochloride is a decongestant having the chemical name: Benzenemethanol, 3-hydroxy-a-[(methylamino)methyl}-, hydrochloride (R)."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children over 12 years of age: One tablet orally every 12 hours."],"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 Drug/Laboratory Test Interactions","Drug Interactions"],"effective_time":"20110315","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 and with other CNS depressants may have an additive effect."],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED Light brown tablets imprinted \"ED\" in bottles of 100 tablets (NDC 0485-0054-01). Dispense in a tight, light-resistant container as defined in the USP. Store at controlled temperature 20°-25°C (68°-77°F). KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN."],"id":"90d4b472-e0f4-485a-bd32-ef6fd1d5adfc","indications_and_usage":["INDICATIONS AND USAGE For the temporary relief of symptoms of seasonal and perennial allergic rhinitis and vasomotor rhinitis including nasal obstruction (congestion)."],"information_for_patients":["Information for Patients"],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers"],"openfda":{},"overdosage":["OVERDOSAGE"],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 6287 CL"],"pediatric_use":["Pediatric Use"],"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 and with other CNS depressants may have an additive effect. Information for Patients Laboratory Tests Interactions Drug Interactions Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy The safety of use of this product in pregnancy has not been established. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use Geriatric Use"],"pregnancy":["Pregnancy The safety of use of this product in pregnancy has not been established. Teratogenic Effects Nonteratogenic Effects"],"set_id":"90d4b472-e0f4-485a-bd32-ef6fd1d5adfc","spl_product_data_elements":["ED-AHIST CHLORPHENIRAMINE AND PHENYLEPHERINE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYPROMELLOSE 2910 (15000 MPA.S) HYDROGENATED COTTONSEED OIL STEARIC ACID CALCIUM PHOSPHATE SILICON DIOXIDE MAGNESIUM STEARATE E;D"],"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 doses higher than the recommended dose nervousness, dizziness, or sleeplessness may occur."]}