{"adverse_reactions":["ADVERSE REACTIONS: Dextromethorphan HBr : Adverse events with Dextromethorphan HBr are rare, but nausea and/or other gastrointestinal disturbances, headaches, slight dizziness and drowsiness sometimes occur. Phenylephrine HCl : Hyper-reactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness or nausea. Sympathomimetics have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias and cardiovascular collapse with hypotension. Chlorpheniramine Maleate : Antihistamines may cause sedation, dizziness, vomiting, diplopia, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria and, rarely, excitability in children."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis and Impairment of Fertility: No data is currently available on long term potential for carcinogenesis, mutagenesis or impairment of fertility in animals or humans."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY: Dextromethorphan HBr is a nonopiod antitussive agent. It suppresses the cough reflex by a direct action on the cough center in the medulla of the brain. Dextromethorphan HBr has no significant analgesic or sedative properties. It does not depress respiration or predispose an individual to addiction with usual doses. In therapeutic dosage, Dextromethorphan HBr does not inhibit ciliary activity. The onset of action is typically within 30 minutes and the duration of action can be up to 6 hours. Dextromethorphan is rapidly and extensively metabolized by the liver. It is primarily excreted in the kidneys as unchanged Dextromethorphan and demethylated metabolites including dextrorphan, an active metabolite. Phenylephrine HCl , a nasal decongestant, is a potent postsynaptic alpha-receptor agonist with little effect on the beta receptors of the heart. Phenylephrine HCl has no effect on the beta-adrenergic receptors of the bronchi or peripheral blood vessels. A direct action at receptors accounts for the greater part of its effects, only a small part being due to its release norepinephrine. Therapeutic doses of phenylephrine HCl may cause vasoconstriction. It increases resistance and, to a lesser extent, decreases capacitance of blood vessels. Total peripheral resistance is increased, resulting in increased systolic and diastolic blood pressure. Pulmonary arterial pressure is usually increased, and renal blood flow is usually decreased. Local vasoconstriction and hemostasis occur following infiltration of phenylephrine HCl into tissues. The main effect of phenylephrine HCl on the heart is bradycardia; it produces a positive inotropic effect on the myocardium in doses greater than those usually used therapeutically. Rarely, the drug may increase the irritability of the heart which can cause arrhythmias. Cardiac output is decreased slightly. Phenylephrine HCl increases the work of the heart by increasing peripheral arterial resistance. Phenylephrine HCl has a mild central stimulant effect. Following oral administration of phenylephrine HCl, constriction of blood vessels in the nasal mucosa relieves nasal congestion associated with allergy or head colds. This may occur within 15 or 20 minutes and may persist for up to 4 hours. Chlorpheniramine Maleate is an alkylamine-type antihistamine which acts by competing with histamine for H1 histamine receptor sites, thereby preventing the action of histamine on the cell. Clinically, chlorpheniramine suppresses the histamine-mediated symptoms of allergic rhinitis, relieving sneezing, rhinorrhea and itching of the eyes, nose and throat."],"contraindications":["CONTRAINDICATIONS: Dextromethorphan HBr, Phenylephrine HCl, Chlorpheniramine Maleate 2.75-1.5-1.0 mg Drops is contraindicated in patients hypersensitive to any of its ingredients.It is also contraindicated in patients with severe hypertension or severe coronary artery disease, or in those receiving monoamine oxidase (MAO) inhibitors. Antihistamines should not be used to treat lower respiratory tract conditions including asthma."],"description":["DESCRIPTION: Each dropperful (1.0 mL) contains: Dextromethorphan HBr 3.0 mg Phenylephrine HCl 1.5 mg Chlorpheniramine Maleate 1.0 mg"],"dosage_and_administration":["DOSAGE* AND ADMINISTRATION: FOR ORAL USE ONLY Children 6 to under 12 years of age – 2 dropperfuls (2.0 mL) Children 2 to under 6 years of age – 1 dropperful (1.0 mL) Children under 2 – As directed by a physician Dosages may be repeated every 4 – 6 hours if required for relief. Not to exceed 4 doses in 24 hours. *Titrate dosage individually."],"drug_interactions":["Drug Interactions: Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.). MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines. MAO inhibitors may enhance the effect of phenylephrine HCl. Sympathomimetics may reduce the effects of antihypertensive drugs."],"effective_time":"20180424","how_supplied":["HOW SUPPLIED: Dextromethorphan HBr, Phenylephrine HCl, Chlorpheniramine Maleate 2.75-1.5-1.0 mg Drops is a sugar-free, alcohol-free, bubblegum flavored liquid and is available in 1 fl. oz. (30 mL) bottles, NDC 42192-509-30, with a calibrated (1.0 mL) dropper. Store at controlled room temperature 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing."],"id":"6a9c6a8e-d239-369d-e053-2a91aa0a5c33","inactive_ingredient":["Inactive Ingredients: Citric Acid, Sodium Citrate, Sodium Saccharin, Sorbitol 70% Solution, Glycerin 99.5% minimum, Propylene Glycol, Fruit Gum Flavor, RD&C Red #40, Purified Water. Dextromethorphan HBr is an antitussive having the chemical name, morphinan, 3-methoxy-17-methyl-, (9α, 13α, 14α)-, hydrobromide, monohydrate, with the following chemical structure: Structure Phenylephrine HCL is a decongestant having the chemical name Benzenemethanol, 3-hydroxy-a-[(methylamino)methyl}-, hydrochloride (R)-, having the chemical structure: Structure3 Chlorpheniramine Maleate is an antihistamine having the chemical name, 2-[?-chloro-a-[2-(dimethylamino) ethyl]benzyl] pyridine Maleate (1:1). Its, strcture is as follows: Structure2"],"indications_and_usage":["INDICATIONS AND USAGE: Dextromethorphan HBr, Phenylephrine HCl, Chlorpheniramine Maleate 2.75-1.5-1.0 mg Drops is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold."],"information_for_patients":["Information for Patients Patients should be warned about engaging in activities requiring mental alertness, such as driving or operating dangerous machinery."],"nursing_mothers":["Nursing Mothers: Some sympathomimetics are excreted in breast milk. Use of this product by nursing mothers is not recommended."],"openfda":{},"overdosage":["OVERDOSAGE: Signs and Symptoms: Overdosage with Dextromethorphan HBr may produce CNS excitement and mental confusion. Overdosage with sympathomimetic amines can cause hypertension, headache, convulsions, cerebral hemorrhage and vomiting may occur. Premature ventricular beats and short paroxysms of ventricular tachycardia may also occur. Headache may be a symptom of hypertension. Bradycardia may also be seen early in Phenylephrine HCl overdosage through stimulation of baroreceptors. Excessive CNS stimulation may result in excitement, tremor, restlessness and insomnia. Other effects may include pallor, mydriasis, hyperglycemia and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, hallucinations, convulsions, or delirium, but in some individuals, there may be CNS depression. Arrhythmias (including ventricular fibrillation) may lead to hypotension and circulatory collapse. Severe hypokalemia can occur, probably due to a compartmental shift rather than a depletion of potassium. Should antihistamine effects predominate, central action constitutes the greatest danger. In the small child, symptoms include excitation, hallucination, ataxia, uncoordination, tremors, flushed face and fever. Convulsions, fixed and dilated pupils, coma and death may occur in severe cases. In the adult, fever and flushing are uncommon; excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed; blood pressure is usually stable. Treatment : The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method; however, vomiting should not be induced in patients with impaired consciousness. Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water. Treatment of the signs and symptoms of overdosage is symptomatic and supportive."],"package_label_principal_display_panel":["Package Labeling: Label9"],"precautions":["PRECAUTIONS: General: Before prescribing this medication to suppress or modify cough, identify and provide therapy for the underlying cause of the cough. Avoid alcohol and other CNS depressants while taking this product. Patients sensitive to antihistamines may experience moderate to severe drowsiness. Information for Patients Patients should be warned about engaging in activities requiring mental alertness, such as driving or operating dangerous machinery. Drug Interactions: Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.). MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines. MAO inhibitors may enhance the effect of phenylephrine HCl. Sympathomimetics may reduce the effects of antihypertensive drugs. Carcinogenesis, Mutagenesis and Impairment of Fertility: No data is currently available on long term potential for carcinogenesis, mutagenesis or impairment of fertility in animals or humans. Pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with this product. It is not known whether this product can cause fetal harm when administered to a pregnant woman or effect reproduction capacity. Give to pregnant woman only if clearly needed. Administration of Phenylephrine HCl to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractibility of the uterus and decreasing uterine blood flow. Nursing Mothers: Some sympathomimetics are excreted in breast milk. Use of this product by nursing mothers is not recommended."],"pregnancy":["Pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with this product. It is not known whether this product can cause fetal harm when administered to a pregnant woman or effect reproduction capacity. Give to pregnant woman only if clearly needed. Administration of Phenylephrine HCl to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractibility of the uterus and decreasing uterine blood flow."],"set_id":"6a9c62c6-56cd-775e-e053-2991aa0ac922","spl_product_data_elements":["Dextromethorphan HBR Phenylephrine HCl DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM SORBITOL GLYCERIN PROPYLENE GLYCOL WATER DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE"],"spl_unclassified_section":["Dextromethorphan HBr, Phenylephrine HCl, Chlorpheniramine Maleate 3.0-1.5-1.0 mg Drops Rx Only","Rx Only MANUFACTURED FOR: Brookstone Pharmaceuticals, LLC 9005 Westside Parkway Alpharetta, GA 30009 1-800-541-4802"],"version":"1","warnings":["WARNINGS: Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage.","WARNING: WARNING: KEEP THIS AND ALL MEDICATION S OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY."]}