{"adverse_reactions":["ADVERSE REACTIONS Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred vision, and increased irritability or excitement (especially in children). 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 Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed."],"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. Methscopolamine nitrate is a quaternary ammonium derivative of the anticholinergic 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. Its antimuscarinic effect causes inhibition of salivary secretions, reduction in volume and total acid content of gastric secretion, and inhibition of gastrointestinal motility. It is poorly and unreliably absorbed. Drug effects appear in about one hour and persist for about 4 to 6 hours. It is excreted primarily in the urine and bile, or as unabsorbed drug in feces."],"contraindications":["CONTRAINDICATIONS This product is contraindicated in patients with hypersensitivity to methscopolamine nitrate and chlorpheniramine maleate. RespiVent™ DF is contraindicated in patients with severe hypertension, severe coronary artery disease, and in nursing mothers. RespiVent™ DF is also contraindicated in patients with narrow-angle glaucoma, and peptic ulcer."],"description":["DESCRIPTION Each AM tablet contains: Chlorpheniramine Maleate. ….4 mg Methscopolamine Nitrate…..2.5 mg Each PM tablet contains: Chlorpheniramine Maleate. ….8 mg Methscopolamine Nitrate…..2.5 mg Chlorpheniramine maleate is an antihistamine having the chemical name 2-pyridinepropanamine, gamma-(4 chlorophenyl)-N, N-dimethyl-, (Z)-2-butenedioate (1:1). Chlorpheniramine maleate Methscopolamine nitrate is an anticholinergic having the chemical name 3-oxa-9-azoniatricyclo [3.3.1.0 2 4 ] nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-,nitrate, [7(S)-(1α, 2β, 4β, 5α, 7β)]; C 17 H 21 NO 4 •CH 3 NO 3 , MW = 80.4 Methscopolamine nitrate Inactive Ingredients: AM tablets: Each white AM tablet contains Hypromellose, Dicalcium Phosphate, Talc, Stearic Acid and Magnesium Stearate. PM tablets: Each blue PM tablet contains Hypromellose, Dicalcium Phosphate, Talc, FD&C Blue #1 (aluminum lake) Dye, Stearic Acid and Magnesium Stearate. Chlorpheniramine maleate Methscopolamine nitrate"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and adolescents 12 years of age and over: One white AM tablet in the morning and one blue PM tablet in the evening. RespiVent™ DF is not recommended for children under 12 years of age."],"drug_interactions":["Drug Interactions Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. Concomitant administration with antacids may interfere with the absorption of methscopolamine nitrate."],"effective_time":"20091027","general_precautions":["General RespiVent™ DF should be used with caution in patients with diabetes mellitus, hypertension, and cardiovascular disease. Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly. Methscopolamine nitrate should be used with caution in the elderly and all patients with autonomic neuropathy, hepatic or renal disease, or ulcerative colitis."],"how_supplied":["HOW SUPPLIED (NDC 24486-704-20) RespiVent™ DF Tablets 10 Day Treatment Regimen, containing 20 tablets as follows: 10 white elongated and scored AM tablets debossed with “CBP” on one side and \"03\" to the right of the score on the other side, each containing 4 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate. 10 blue, elongated and scored PM tablets debossed with “CBP” on one side and \"02\" to the right of the score on the other side, each containing 8 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate. (NDC 24486-704-60) RespiVent™ DF Tablets 30 Day Treatment Regimen, containing 60 tablets as follows: 30 white elongated and scored AM tablets debossed with “CBP” on one side and \"03\" to the right of the score on the other side, each containing 4 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate. 30 blue, elongated and scored PM tablets debossed with “CBP” on one side and \"02\" to the right of the score on the other side, each containing 8 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate. (NDC 24486-704-02) RespiVent™ DF Tablets 2-pack sample containing 1 white AM tablet and 1 blue PM tablet per sample. Keep out of reach of pediatric population. Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). See USP Controlled Room Temperature. Distributed by Aristos Pharmaceuticals, LLC., Cary, NC 27518. Patent Pending Aristos Pharmaceuticals ARR202A0108 Aristos Pharmaceuticals"],"id":"23602bf4-875f-4afa-8aaa-b08a36f93593","indications_and_usage":["INDICATIONS AND USAGE For the temporary relief of symptoms associated with allergic rhinitis."],"nursing_mothers":["Nursing Mothers It is not known whether this combination drug is excreted in human milk."],"openfda":{},"overdosage":["OVERDOSAGE AND TREATMENT OF OVERDOSAGE The treatment of overdosage should provide symptomatic and supportive care. Induction of emesis and gastric lavage may be performed if the patient is alert and seen within early hours after ingestion. Drug remaining in the stomach may be absorbed by the administration of activated charcoal. Since the effects of RespiVent™ DF last up to 12 hours, the patient should be monitored for at least that length of time and treated as necessary."],"package_label_principal_display_panel":["RespiVent Dose Pack DF RespiVent Dose Pack DF"],"pediatric_use":["Pediatric Use The safety and effectiveness in children under 12 years of age have not been established."],"precautions":["PRECAUTIONS General RespiVent™ DF should be used with caution in patients with diabetes mellitus, hypertension, and cardiovascular disease. Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly. Methscopolamine nitrate should be used with caution in the elderly and all patients with autonomic neuropathy, hepatic or renal disease, or ulcerative colitis. Drug Interactions Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. Concomitant administration with antacids may interfere with the absorption of methscopolamine nitrate. Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed. Pregnancy Category C It is not known whether RespiVent™ DF can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RespiVent™ DF should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this combination drug is excreted in human milk. Pediatric Use The safety and effectiveness in children under 12 years of age have not been established. Geriatric Use The elderly (60 years and older) are more likely to experience adverse reactions to methscopolamine.","Geriatric Use The elderly (60 years and older) are more likely to experience adverse reactions to methscopolamine."],"pregnancy":["Pregnancy Category C It is not known whether RespiVent™ DF can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RespiVent™ DF should be given to a pregnant woman only if clearly needed."],"set_id":"89a941ee-7121-4208-af85-aaf8d810b444","spl_product_data_elements":["RespiVent Dosepack DF Chlorpheniramine Maleate Methscopolamine Nitrate Chlorpheniramine Maleate Methscopolamine Nitrate Chlorpheniramine Maleate Methscopolamine Nitrate CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE METHSCOPOLAMINE NITRATE METHSCOPOLAMINE HYPROMELLOSES ANHYDROUS DIBASIC CALCIUM PHOSPHATE TALC STEARIC ACID MAGNESIUM STEARATE white CBP;03 Chlorpheniramine Maleate Methscopolamine Nitrate Chlorpheniramine Maleate Methscopolamine Nitrate CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE METHSCOPOLAMINE NITRATE METHSCOPOLAMINE HYPROMELLOSES ANHYDROUS DIBASIC CALCIUM PHOSPHATE TALC FD&C BLUE NO. 1 STEARIC ACID MAGNESIUM STEARATE CBP;02"],"version":"10","warnings":["WARNINGS Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Do not exceed recommended dosage. Methscopolamine nitrate may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or performing hazardous work while taking RespiVent™ DF. Co-administration of sildenafil citrate and other organic nitrates has been shown to potentiate the hypotension effects of nitrates. Co-administration of RespiVent™ DF and sildenafil citrate has not been studied. Therefore, the use of sildenafil citrate and RespiVent™ DF together is not recommended."]}