{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Adverse reactions include drowsiness, nausea, dryness of mouth, blurred vision, cardiac palpitation, increase irritability to 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 antihistamine is among the most active histamine antagonists and is generally effective in relatively low doses. The drugs are not o prove 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 sympathemimetic which acts predominantly on alpha receptors and hac little action on beta receptors. If 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 antisecretary 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 attact."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each PRE-HIST-D EXTENDED RELEASE TABLET contains: Chlorpheniramine Maleate ........................................... 8mg Phenylephrina Hydrochloride ....................................... 20mg Methscopolamine Nitrate ............................................. 2.5mg In a specially prepared base to provide a prolonged therapeutic effect. Chorpheniramine is an antihistamine having the chemical name 2 - pyridinepropenamine, gamma (4 chlorosphasyl)-N, N-dimethyl, (Z) 2-butenedicate (1:1). Phenylephrine HCI is a decongestant having the chemical name Benzene-methanol, 3 hydroxy-alpha-(methylamine) methyl-hydrochloride. Methscopolamine is an anticholinergic having the chemical name 3-Oxa-9-azonlatricycle (3.3.1.0) noname, 7-(3-hydroxyl-oxo2-phenylpropoxy) -9, 9-dimethyl, nitrate (7(s)-(l alpha, w beta, 4 beta, 5 alpha, 7 beta). PRE-HIST-D Tablets contain ingredients of the following therapeutic classes: nasal decongestant, antihistamine, and antisecrolory agent."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION PRE-HIS-D EXTENDED RELEASE TABLETS: Adults and children 12 years and older, one PRE-HIST-D 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 MAOinhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamitamine, reserpine and veranium alkaloids. Concomitant use of antihistamines with alcohol and other CNS depressants may have an addictive effect. Drug/Laboratory Test Interactions","Drug Interactions MAOinhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamitamine, reserpine and veranium alkaloids. Concomitant use of antihistamines with alcohol and other CNS depressants may have an addictive effect."],"effective_time":"20110318","general_precautions":["General Caution should be exercised in patients with high blood pressure, heart disease, diabeter or thyroid disease. The antihistamine in this product may exhibit addictive effects with other CNS depressants, including alcohol."],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED PRE-HIST-D EXTENDED RELEASE TABLETS: Bottles of 100 (NDC 0682-0100-01) white, scored tablets embossed with \"CPM\" on one side and \"M/D\" on the other. Store at controlled room temperature 15 o -30 o C (59 o -86 o F). Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure."],"id":"74872b83-650b-4b99-af9f-b8da514a448c","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 high fever."],"information_for_patients":["Information for Patients Antihistamine may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cationed 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 PRE-HIST-D is administered to a nursing woman."],"openfda":{},"overdosage":["OVERDOSAGE In all cases of suspected overdose, immediately call your regional poison center, and/or contact a physician immediately. The stomach should be emptied promptly by lavage or by induction of emesis with syrup. 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 should be used."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 6280 SPL"],"pediatric_use":["Pediatric Use"],"precautions":["PRECAUTIONS General Caution should be exercised in patients with high blood pressure, heart disease, diabeter or thyroid disease. The antihistamine in this product may exhibit addictive 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 cationed accordingly. Laboratory Tests Interactions Drug Interactions MAOinhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamitamine, reserpine and veranium alkaloids. Concomitant use of antihistamines with alcohol and other CNS depressants may have an addictive effect. Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Category C: it is not known whether PRE-HIST-D can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PRE-HIST-D 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 PRE-HIST-D is administered to a nursing woman. Pediatric Use Geriatric Use"],"pregnancy":["Pregnancy Category C: it is not known whether PRE-HIST-D can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PRE-HIST-D should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"74872b83-650b-4b99-af9f-b8da514a448c","spl_product_data_elements":["PREHIST CHLORPHENIRAMINE, PHENYLEPHRINE, and METHSCOPOLAMINE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE METHSCOPOLAMINE NITRATE NITRATE ION HYPROMELLOSE 2910 (15000 MPA.S) HYDROGENATED COTTONSEED OIL STEARIC ACID ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE MAGNESIUM STEARATE CPM"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS Considerable caution should be exercised in patients with hypertension, diabetes melitus, 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 sleepiness may occur."]}