{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Sympathomimetic amines may cause tachycardia, palpitations, nervousness, insomnia, restlessness, headache, gastric irritation and irritability. Sympathomimetic amines have been associated with certain untoward reactions including fear, anxiety, tenseness, restlessness, tremor, weakness, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions. CNS depression, arrhythmias and cardiovascular collapse with hypotension. Urinary retention may occur in patients with prostatic hypertrophy. Antihistamines and anticholinergics may cause drowsiness, dizziness, blurred vision and excessive dryness of the nose, throat and mouth."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Pseudoephedrine HCI is rapidly and almost completely absorbed from the gastrointestinal tract. It has a plasma half-life of 6 to 8 hours. Acidic urine is associated with faster elimination of the drug. The drug is distributed to body tissues and fluids including the fetal tissues, breast milk and the central nervous system (CNS). Approximately 50% to 75% of the administered dose is excreted unchanged in the urine; this remainder is apparently metabolized in the liver to inactive compounds by N-demethylation, parahydroxylation and oxidative deamination. Dexchlorphenitramine maleate is an alkylamine-type antihistamine that possesses anticholinergic and sedative effects. Antihistamines competitively antagonize histamine at the H 1 receotir site. Thus, activation of H 1 receptors by released histamine, which results in increased vascular permeability, increased mucus production, pruritis and sneezing, is prevented. Methoscopolamine nitrate is a quaternary ammonium derivative of the anticholinergic scopolamine, which possesses the peripheral actions of the belladona alkaloids, but does not exhibit the central actions because of its lack of ability to cross the blood brain border. Its antimuscarinic effect causes drying of mucus secretions."],"contraindications":["CONTRAINDICATIONS Patients with hypersensitivity or idiosyncrasy to any of its ingredients. Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease and patients on monoamine oxidase (MAO) inhibitor therapy. Antihistamines and anticholinergics are contraindicated in patients with narrow angle glaucoma, urinary retention, peptic ulcer and during an asthma attack."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION This product contains ingredients of the following therapeutic classes: antihistamine, decongestant and anticholinergic. Inactive Ingredients: dicalcium phosphate, hypromellose, stearic acid, polyvinylpynolidone, white coating (titanium dioxide, hypromellose, polyethylene glycol, sodium citrate, polysorbate 80) silicon dioxide, and magnesium stearate."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children 12 years of age and older: One caplet twice daily (every 12 hours) not to exceed 2 caplets in 24 hours. Children 6 - 12 years: One-half (1/2) caplet every 12 hours not to exceed 1 caplet in 24 hours. D-Hist D is not recommended for children under 6 years of age. Caplets 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 (1) Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the efect of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of metyldopa, mecamylamine and roserpine. (2) Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetic may reduce the hypotensive effects of gunahidine, mecamylamine, methyldopa, roserpine and veratrum alkaloids. Concurrent use of tricylic antidepressants may antagonize the effects of pseudoephedrine. Concomitant use of antihistamines with alcohol, tryciclic antidepressants, barbiturates and other CNS depressants may have an addictive effects. Drug/Laboratory Test Interactions","Drug Interactions (1) Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the efect of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of metyldopa, mecamylamine and roserpine. (2) Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetic may reduce the hypotensive effects of gunahidine, mecamylamine, methyldopa, roserpine and veratrum alkaloids. Concurrent use of tricylic antidepressants may antagonize the effects of pseudoephedrine. Concomitant use of antihistamines with alcohol, tryciclic antidepressants, barbiturates and other CNS depressants may have an addictive effects."],"effective_time":"20110311","general_precautions":["General Use with caution in patients with diabetes, hypertension, cardiovascular disease and hyperreactivity to sympathomimetic amines. Antihistamines may cause drowsiness and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly."],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED D-Hist D is available in a white, scored caplet imprinted with \"ML |180\" on one side, and plain on the other. Bottles of 100 (NDC 08308-180-10) Store at controlled room temperature, 15 o - 30 o C (15 o - 86 o F). Dispense in tight, light resistant containes (USP/NF)."],"id":"b00ff7bd-f96d-4bb4-b514-16b972c7c040","indications_and_usage":["INDICATIONS AND USAGE For symptomatic relief of seasonal and parental allergic rinitis and vasomotor."],"information_for_patients":["Information for Patients Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Do not crush or chew D-Hist D caplets prior to swallowing. The antihistamine in this product may have addictive effects with alcohol and other central nervous system depressant (hypnotics, sedatives, tranquilizers)."],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers Pseudoephedrine is excreted in breast milk. Use of this product by nursing mothers is not recommended because of the higher than usual risk for infants from sympathomimetic amines."],"openfda":{},"overdosage":["OVERDOSAGE The tratment of overdosage should provide symptomatic and supportive care. Induction of amesis and gastric lavage may be performed if the patient is alert and seen within early hours after ingestion. Either isolonic or half-isolonic sline may be used for lavage. Administration of an activated charcoal slurry is beneficial after lavage and/or emesis if less than 4 hours have passed since ingestion. Stimulants should not be used because they may precipitate convulsions. Use of a short-acting barbiturate is recommended if convulsions or marked CNS excitement occur. Since the effects of D-Hist D may last up to 12 hours, the patient should be monitored for at least that length of time and treated as necessary. The LD 50 ol pseudoephedrine (single oral dose) has been reported to be 726 mg/kg in the mouse, 2205 mg/kg in the rat and 1177 mg/kg in the rabbit. The toxic and lethal concentrations in human biologic fluids are not known. Urinary excretion increases with acidification and decreases with alkalinazation if the urine. There are few published reports of toxicity due to pseudoephedrine and no case or fatal overdosage has been reported. In severe cases of overdosage it is essential to monitor both the heart (by electrocardiograph) and plasma electrolyles, and to pive intravenous potassium as indicated. Vasopressors may be used to treat hypotension. Excessive CNS stimulation may be counteracted with parenteral diazapem. Stimulants should not be used."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label 7086 cl"],"pediatric_use":["Pediatric Use Safety and effectiveness of D-Hist D in children below the age of 6 have not been established."],"precautions":["PRECAUTIONS General Use with caution in patients with diabetes, hypertension, cardiovascular disease and hyperreactivity to sympathomimetic amines. Antihistamines may cause drowsiness and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly. Information for Patients Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Do not crush or chew D-Hist D caplets prior to swallowing. The antihistamine in this product may have addictive effects with alcohol and other central nervous system depressant (hypnotics, sedatives, tranquilizers). Laboratory Tests Interactions Drug Interactions (1) Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the efect of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of metyldopa, mecamylamine and roserpine. (2) Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetic may reduce the hypotensive effects of gunahidine, mecamylamine, methyldopa, roserpine and veratrum alkaloids. Concurrent use of tricylic antidepressants may antagonize the effects of pseudoephedrine. Concomitant use of antihistamines with alcohol, tryciclic antidepressants, barbiturates and other CNS depressants may have an addictive effects. Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy Category C: Animal reproduction studies have not been conducted with D-Hist D. It is also not known whether D-Hist D can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. D-Hist D should be given to a pregnant woman only if clearly neede. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Pseudoephedrine is excreted in breast milk. Use of this product by nursing mothers is not recommended because of the higher than usual risk for infants from sympathomimetic amines. Pediatric Use Safety and effectiveness of D-Hist D in children below the age of 6 have not been established. Geriatric Use"],"pregnancy":["Pregnancy Category C: Animal reproduction studies have not been conducted with D-Hist D. It is also not known whether D-Hist D can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. D-Hist D should be given to a pregnant woman only if clearly neede. Teratogenic Effects Nonteratogenic Effects"],"set_id":"b00ff7bd-f96d-4bb4-b514-16b972c7c040","spl_product_data_elements":["D HIST D Pseudoephedrine, Dexchlorpheniramine, Methscopolamine PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE DEXCHLORPHENIRAMINE MALEATE DEXCHLORPHENIRAMINE METHSCOPOLAMINE NITRATE METHSCOPOLAMINE CROSPOVIDONE ANHYDROUS DIBASIC CALCIUM PHOSPHATE HYDROXYPROPYL CELLULOSE SILICON DIOXIDE STEARIC ACID MAGNESIUM STEARATE ML;180"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes, ischemic heart disease, hypothyroidism, increased intraocular pressure, and prostatic hyperthrophy. Sympathomimetic amines may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypertension. The elderly (60 years and older) are more likely to exhibit adverse reaction. Antihistamines may cause excitability, especially in children. A dosages higher than the recommended dose, nervousness, dizziness or sleepiness may occur. Do not exceed recommended dosage."]}