{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS The following adverse reactions have been observed with the use of phenylephrine, chlorpheniramine and methscopolamine: arrhythmias, blood dyscrasias, CNS depression, CNS stimulation, dizziness, drowsiness, dryness of mouth, hallucinations, hypotension, hypertension, increased sensitivity of skin to sun, increased sweating, loss of appetite, paradoxical reaction, restlessness, skin rash, stomach upset or pain, thickening of mucus, tingling in hands of feet, trembling, troubled breathing, unusual tiredness or weakness, vomiting. Note: Agitation; confusion; difficulty or painful urination; drowsiness; dizziness; and dryness of mouth, nose or throat are more likely to occur in the elderly. Nightmares, unusualexcitement, nervousness, restlessness, or irritability are more likely to occur in children and the elderly. When anticholinergics are given to patients, especially children, where environmental temperature is high, there is risk of a rapid increase in body temperature."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis or impairment of fertility in animals or humans."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Phenylephrine, a sympathomimetic amine, acts directly on α adrenergic recptors in the mucosa of the respiratory tract to produce vasoconstriction that increases peripheral resistance, resulting in an increase in both systolic and diastolic blood pressure. Accompanying the pressor response is a marked reflex bradycardia due to increased vagal activity. It produces vasoconstriction that lasts longer than that produced by ephedrine and epinephrine, and in therapeutic doses, produces little or no central nervous system (CNS) stimulation. Phenylephrine has reduced bioavailability from the gastrointestinal tract because of first pass metabolism by monoamine oxidase in the stomach and liver. Chlorpheniramine maleate competitively antagonizes most of the smooth muscle stimulating actions of histamine on the H1 receptors of the G tract, uterus, large blood vessels, and bronchial muscle. It also antagonizes the action of histamine that results in increased capillary permeability and the formation of edema. 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. They thereby prevent, but do not reverse, responses mediated by histamine alone. The anticholinergic actions of most antihistamines provide a drying effect on the nasal mucosa. These drugs are not so prone to produce drowsiness and are among the most suitable agents for daytime use, but a significant proportion of patients do experience this effect. Methscopolamine nitrate is one of the principal anticholinergic/antispasmodic components of the belladonna alkaloids that exhibits antisecretory activity. Methscopolamine inhibits the muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves; smooth muscle, cardiac muscle, sinoatrial and atrioventricular nodes, and exocrine glands. In general, the smaller doses of anticholinergics inhibit salivary and bronchial secretions, sweating, and accommodation; cause dilation of the pupil; and increase the heart rate."],"contraindications":["CONTRAINDICATIONS This product is contraindicated in women who are pregnant or nursing, This product is contraindicated in children under six years of age, because this age group is sensitive to the effects of sympathomimetic amines. It is also contraindicated in newborn or premature infants, because this age group has an increased susceptibility to the anticholinergic side effects of chlorpheniramine maleate. Geriatric patients may be more sensitive to the effects of this medication. Risk-benefit should be considered when the following conditions exist. Sensitivity to phenylephrine, chlorpheniramine or methscopolamine; asthma, acute, bladder neck obstruction; brain damage, in children; cardiac disease, especially cardiac arrhythmias; congestive heart failure, coronary artery disease, and mitral stenosis; cardiovascular disease; diabetes mellitus; Down's Syndrome; esophagitis, reflux; glaucoma; hemorrhage, acute, with unstable cardiovascular status; hepatic function impairment; hernia, hypertension, hyperthyroidism; intestinal atony in the elderly or debilitated patient; lung disease, chronic; myasthenia gravis; neuropathy, autonomic paralytic ileus; prostatic hyperthrophy; psychosis or other pshychiatric disorders; pyloric obstruction; renal function impairment; spastic paralysis, in children; tachycardia; toxemia of pregnancy; ulcerative colitis; urinary retention, or predisposition to; uropathy; xerostomia."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each AH-Chew ® II scored chewable tablet contains: Phenylephrine HCI ........................... 15mg Chlorpheniramine Maleate ................ 2mg Methscopolamine Nitrate .................. 1.25mg Phenylephrine HCI is a sympathomimetic amine with the chemical structure: Benzenemethanol, 3-hydroxy - α (methylamino) methyl, hydrochloride (R)."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults anc children over 12 years of age: 1-2 tablets every 4-6 hours, not to exceed eight tablets daily. Children 6 to 12 years: 1 tablet every 4-6 hours, not to exceed four tablets daily. Under 6 yrs: As recommended by a physician. Note: Geriatric patients may be more sensitive to the effects of the usual adult dose."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Central nervous system stimulants such as phenylephrine have been abused. At high doses, subjects commonly experience an elevation of mood, a sense of increased energy and alertness, and decreased appetite. Some individuals become anxious, irritable and loquacious. In addition to the marked euphoria, the user experiences a sense of markedly enhanced physical strength and mental capacity. With continued use, tolerance develops, the user increases the dose, and toxic signs and symptoms appear. Depression may follow rapid withdrawal. Stimulants, such as phenylephrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA). Controlled Substance Abuse Dependence"],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions"],"drug_interactions":["Interactions Anthihistamines may interfere with diagnostic test results for skin tests using allergen extracts. Anticholinergics may interfere with diagnostic test results for gastric acid secretion by antagonizing the effect of pentagastrin and histamine, and for radionuclide gastric emptying studies by delaying gastric emptying. Drug Interactions Drug/Laboratory Test Interactions","Drug Interactions"],"effective_time":"20110330","general_precautions":["General Use phenylephrine with caution in patients with hypoxia, acidosis, or a history of arteriosclerosis, bradycardia, partial heart block, hypertention, myocardial disease, thrombosis, or ventricular tachycardia. Antihistamines have an atropine-like action and should be used with caution in patients with a history of bronchial asthma, emphysema, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension. Use methscopolamine with caution and only when needed in patients with hiatal hernia associated with reflux esophagitis. Use extreme caution and only when needed in patients with autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, and cardiac arrhythmia. Investigate any tachycardia before giving anticholinergic drugs since they may increase the heart rate. Prolonged use of anticholinergics may decrease or inhibit salivary flow, thus contributing to the development of caries, periodental disease, oral candidiasis and discomfort. Methyldopa - In addition to possibly decreasing the hypotensive effects of these medications, concurrent use may enhance the pressor response to phenylephrine; caution is required with very small initial doses of methyldopa being administered. MAO inhibitors - Concurrent use may prolong and intensify cardiac stimulant and vasopressor effects of phynylephrine and chlorpheniramine because of the release of catecholamines, resulting in headaches, cardiac arrhythmias, vomiting or sudden and severe hypertensive and/or hyperpyrexic crises. These medications should not be administered during or within 14 days following the administration of MAO inhibitor therapy. Potassium chloride - Concurrent use with anticholinergics may increase the severity of potassium chloride - induced gastrointestinal lesions. Rauwolfia alkaloids - Concurrent use may prolong the direct-acting sympathomimetic amines by preventing the uptake into storage granules."],"geriatric_use":["Geriatric Use Confusion, hallucinations, seizures and CNS depression may be more likely to occur in geriatric patients taking sympathomimetic amines. Geriatric patients also may be more sensitive to the effects, especially the vasopressor effects, of sympathomimetic amines. Confusion, dizziness, sedation hypotension, hyperexcitability, and anticholinergic side effects, such as dryness of mouth and urinary retention (especially in males), may be more likely to occur in geriatric patients taking antihistamines. Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion. Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males). If these side effects occur and continue or are severe, medication should probably be discontinued. Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma. Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of anticholinergics, since these drugs block the action of acetylcholine, which is responsible for many functions of the brain, including memory function."],"how_supplied":["HOW SUPPLIED Ah-Chew ® II Chewable Tablets are available as purple, scored tablets with the logo \"WE\" scored \"33\" in bottles of 100. NDC 59196-0033-01. Samples of 8 NDC 59196-0033-02. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Dispense in tight, light-resistant containers as described in the USP/NF. Store at controlled room temperature 20 o -25 o C (68 o -77 o F)"],"id":"07e3d25b-bcab-42fb-9f01-06700d5ba32e","indications_and_usage":["INDICATIONS AND USAGE This product provides relief of the symptoms resulting from irritation of sinus, nasal, and upper respiratory tract tissue. Phenylephrine exerts a vasoconstrictive and decongestive action while chlorpheniramine maleate decreases the symptoms of watery eyes, postnasal drip, and sneezing. Methscopolamine nitrate further augments the antisecretory activity of the product."],"information_for_patients":["Information for Patients"],"labor_and_delivery":["Labor and Delivery Use of phenylephrine during labor may cause fetal anoxia and bradycardia by increasing contractility of the uterus and decreasing uterine blood flow."],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers Small amounts of sympathomimetic amines and antihistamines are excreted in breast milk; use is not recommended because of the risk of adverse effects, such as unusual excitement or irritability, in infants. Anticholinergics and antihistamines may inhibit lactation."],"openfda":{},"overdosage":["OVERDOSAGE This product is compromised of pharmacologically different components (sympathomimetic amine, antihistamine, and anticholinergic). Therefore, it is difficult to predict the exact manifestation of symptoms in a given individual. Reaction to an overdose of this product may vary from CNS depression to stimulation. A description of symptoms which are likely to appear after ingestion of an excess of the individual components follows: Overdosage with sympathomimetic amines can cause cardiac arrhythmias, cerebral hemorrhage and pulmonary edema. It can cause palpitations, tremor, dizziness, vomiting, fear, labored breathing, headache, dryness of mouth, pallor, weakness, panic, anxiety, confusion and hallucination. Manifestation of antihistamine overdosage may vary from CNS depression to stimulation. Other signs and symptoms may be dizziness, tinnitus, ataxia, blurred vision, and hypotension. Stimulation is particularly likely in children as are atropine-like signs and symptoms (dry mouth, fixed and dilated pupils, flushing, hyperthermia, and gastrointestinal symptoms). In infants and children particulary, antihistamines in overdosage may produce convulsion and/or death. The signs and symptoms of overdosage of anticholinergics are headache, nausea, vomiting, blurred vision, fixed and dilated pupils, hot dry skin, dizziness, dryness of mouth, difficulty in swallowing, and CNS stimulation. Treatment of acute overdosage would probably be based upon treating the patient for phenylephrine toxicity which may manifest itself as excessive CNS stimulation resulting in excitement, tremor, restlessness, and insomnia. Other effects may include hyperpyrexia, hypertension, mydriasis, hyperglycemia and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, convulsions or delirum, but in some individuals there may be CNS depression with somnolence, stupor, or respiratory depression, Arrhythmias may lead to hypertension and circulatory collapse. Severe hypokalemia can occur, probably due to a compartmental shift rather than a depletion of potassium. No organ damage or significant metabolic derangement is associated with overdosage."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label 6741 CL"],"pediatric_use":["Pediatric Use Use of antihistamines is not recommended in newborn or premature infants because this age group has increased susceptibility to anticholinergic side effects, such as CNS excitation, and an increased tendency toward convulsion. In infants and children, overdosage may cause hallucinations, convulsions, and death. A paradoxical reaction characterized by hyperexcitability may occur in older children taking antihistamines. Use is not recommended for children under six years of age. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for infants and children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients and dosage adjustments are often required. When anticholinergics are given to children when the environmental temperature is high, there is a risk of rapid increase in body temperature because of suppression of sweat gland activity. A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics. Appropriate studies with phenylephrine have not been performe in the pediatric population; however, no pediatric specific problems have been documented to date."],"precautions":["PRECAUTIONS General Use phenylephrine with caution in patients with hypoxia, acidosis, or a history of arteriosclerosis, bradycardia, partial heart block, hypertention, myocardial disease, thrombosis, or ventricular tachycardia. Antihistamines have an atropine-like action and should be used with caution in patients with a history of bronchial asthma, emphysema, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension. Use methscopolamine with caution and only when needed in patients with hiatal hernia associated with reflux esophagitis. Use extreme caution and only when needed in patients with autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, and cardiac arrhythmia. Investigate any tachycardia before giving anticholinergic drugs since they may increase the heart rate. Prolonged use of anticholinergics may decrease or inhibit salivary flow, thus contributing to the development of caries, periodental disease, oral candidiasis and discomfort. Methyldopa - In addition to possibly decreasing the hypotensive effects of these medications, concurrent use may enhance the pressor response to phenylephrine; caution is required with very small initial doses of methyldopa being administered. MAO inhibitors - Concurrent use may prolong and intensify cardiac stimulant and vasopressor effects of phynylephrine and chlorpheniramine because of the release of catecholamines, resulting in headaches, cardiac arrhythmias, vomiting or sudden and severe hypertensive and/or hyperpyrexic crises. These medications should not be administered during or within 14 days following the administration of MAO inhibitor therapy. Potassium chloride - Concurrent use with anticholinergics may increase the severity of potassium chloride - induced gastrointestinal lesions. Rauwolfia alkaloids - Concurrent use may prolong the direct-acting sympathomimetic amines by preventing the uptake into storage granules. Information for Patients Laboratory Tests Interactions Anthihistamines may interfere with diagnostic test results for skin tests using allergen extracts. Anticholinergics may interfere with diagnostic test results for gastric acid secretion by antagonizing the effect of pentagastrin and histamine, and for radionuclide gastric emptying studies by delaying gastric emptying. Drug Interactions Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on the long-term potential of the components of this product for carcinogenesis, mutagenesis or impairment of fertility in animals or humans. Pregnancy Category C: Reproduction studies have been performed with chlorpheniramine maleate. Studies in rabbits and rats at doses up to 50 times and 85 times the human dose revealed no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Therefore, it is not known whether these drugs can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with phenylephrine or methscopolamine. This product should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Use of phenylephrine during labor may cause fetal anoxia and bradycardia by increasing contractility of the uterus and decreasing uterine blood flow. Nursing Mothers Small amounts of sympathomimetic amines and antihistamines are excreted in breast milk; use is not recommended because of the risk of adverse effects, such as unusual excitement or irritability, in infants. Anticholinergics and antihistamines may inhibit lactation. Pediatric Use Use of antihistamines is not recommended in newborn or premature infants because this age group has increased susceptibility to anticholinergic side effects, such as CNS excitation, and an increased tendency toward convulsion. In infants and children, overdosage may cause hallucinations, convulsions, and death. A paradoxical reaction characterized by hyperexcitability may occur in older children taking antihistamines. Use is not recommended for children under six years of age. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for infants and children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients and dosage adjustments are often required. When anticholinergics are given to children when the environmental temperature is high, there is a risk of rapid increase in body temperature because of suppression of sweat gland activity. A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics. Appropriate studies with phenylephrine have not been performe in the pediatric population; however, no pediatric specific problems have been documented to date. Geriatric Use Confusion, hallucinations, seizures and CNS depression may be more likely to occur in geriatric patients taking sympathomimetic amines. Geriatric patients also may be more sensitive to the effects, especially the vasopressor effects, of sympathomimetic amines. Confusion, dizziness, sedation hypotension, hyperexcitability, and anticholinergic side effects, such as dryness of mouth and urinary retention (especially in males), may be more likely to occur in geriatric patients taking antihistamines. Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion. Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males). If these side effects occur and continue or are severe, medication should probably be discontinued. Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma. Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of anticholinergics, since these drugs block the action of acetylcholine, which is responsible for many functions of the brain, including memory function."],"pregnancy":["Pregnancy Category C: Reproduction studies have been performed with chlorpheniramine maleate. Studies in rabbits and rats at doses up to 50 times and 85 times the human dose revealed no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Therefore, it is not known whether these drugs can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with phenylephrine or methscopolamine. This product should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"07e3d25b-bcab-42fb-9f01-06700d5ba32e","spl_product_data_elements":["AH CHEW II Chlorpheniramine Phenylephrine and Methscopolamine CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE METHSCOPOLAMINE NITRATE METHSCOPOLAMINE FD&C BLUE NO. 2 D&C RED NO. 30 CITRIC ACID MONOHYDRATE XYLITOL SILICON DIOXIDE GRAPE MAGNESIUM STEARATE STEARIC ACID WE;33"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such a operating a motor vehicle or other machinery, or to perform hazardous tasks while taking this drug. Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hyperthrophy. Sympathomimetic amines in overdosage my produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage. Antihistamines should be used with considerable caution in pyloroduodenal obstruction; symptomatic prostatic hypertrophy; bladder neck obstruction. 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. Heat prostration can occur with methscopolamine used where the environmental temperature is high. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, use of methscopolamine would be inappropriate and possible harmful."]}