{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Dexchlorpheniramine Maleate Slight to moderate drowsiness may occur and is the mo frequent side effect. Other possible side effects of antihistamines include: General: urticaria, drug rash, anaphylactic shock photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat; Cardiovascular: hypotension, headache palpitation, tachycardia, extrasystoles; Hematologic: hemolytic anemia, thrombocytopenia, granulocytosis; CNS: sedation, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, hysteria, neuritis, convulsion; Gastrointestinal: epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation; Genitourinary: urinary frequency, difficult urination, urinary retention, early menses; Respiratory: thickening of bronchial secretions, tightness of chest, wheezing and nasal stuffiness. Pseudoephedrine HCI Pseudoephedrine may cause mild central nervous system stimulation, especially in those patients who are hypersensitive to sympathomimetic drugs. Nervousness, excitability, restlessness, dizziness, weakness and insomnia may also occur. Headache and drowsiness have also been reported. Large doses may cause lightheadedness, nausea and/or vomiting. Sympathomimetic drugs have also been associated with certain untoward reactions including fear, anxiety, tenseness, restlessness, tremor, weakness, pallor. respiratory difficulty, dysuria, insomnia, hallucination, convulsion, CNS depression, arrhythmias and cardiovascular collapse with hypotension."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed with Hexaflu®."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic. Its therapeutic effects are due to the inhibition of the synthesis of prostaglandins and the hypothalamic heat-regulating center. Dexchlorpheniramine maleate antagonizes the physiological action of histamine by acting as an H1 receptor blocking agent. In vitro and in vivo assays of the antihistamine potencies of the optically active isomers of chlorpheniramine demonstrate that the predominant activity is in the dextro-isomer. The dextro-isomer is approximately two times more active than the racemic compound. Pseudoephedrine HCI is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. It does this by vasoconstriction, which results in reduction of tissue hyperemia, edema, nasal congestfon and an increase in nasal airway patency. The vasoconstrictive action of pseudoephedrine is similar to that of ephedrine. In the usual dose it has minimal vasopressor effects"],"contraindications":["CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Do not use in patients receiving MAO inhibitors. Sympathomimetic amines are contraindicated in patients with severe hypertension and coronary artery disease"],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each white film coated tablet contains dexchlorpheniramine maleate 2mg, pseudoephedrine HCI 45mg, and acetaminophen 650mg. Hexaflu® tablets contain ingredients of the following therapeutic classes: antihistamine, decongestant, anti-pyretic, and analgesic. Hexaflu® tablets do not contain sugar, lactose or dyes."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children 12 years of age and older: One tablet four times per day not to exceed 4 tablets in 24 hours. Children 6-12: One-half tablet four times per day not to exceed 2 tablets in 24 hours. Hexaflu® Is not recommended for children under 6 years of age. Tablets may be broken in hall for ease of administration. Do not crush or chew tablets. Geriatric patients may be more sensitive to the effects of this medication and it may cause excitability in children. Adjust adult dose accordingly."],"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 Do not use in patients receiving prescription monoamine oxidase inhibitor (MAO I) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If patients do not know if their prescription drug contains an MAOI, they should ask a doctor or pharmacist before taking this product. MAO inhibitors also prolong and intensify the anticholinergic effects of antihistamines. Sympathomimetics may reduce the antihypertensive effect of methyldopa, reserpine, veratrum alkaloids and mecamylamine. Alcohol and other sedative drugs will potentiate the sedative effects of dexchlorpheniramine. Care should be taken in administering this product concomitantly with other sympathomimetic amines since their combined effects or the cardiovascular system may be harmful to the patient. Drug/Laboratory Test Interactions","Drug Interactions Do not use in patients receiving prescription monoamine oxidase inhibitor (MAO I) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If patients do not know if their prescription drug contains an MAOI, they should ask a doctor or pharmacist before taking this product. MAO inhibitors also prolong and intensify the anticholinergic effects of antihistamines. Sympathomimetics may reduce the antihypertensive effect of methyldopa, reserpine, veratrum alkaloids and mecamylamine. Alcohol and other sedative drugs will potentiate the sedative effects of dexchlorpheniramine. Care should be taken in administering this product concomitantly with other sympathomimetic amines since their combined effects or the cardiovascular system may be harmful to the patient."],"effective_time":"20110316","general_precautions":["General"],"geriatric_use":["Geriatric Use Patients 60 years and older are more likely t experience adverse reactions to sympathomimetics. Overdos may cause hallucinations, convulsions, CNS depression and death."],"how_supplied":["HOW SUPPLIED Hexaflu® is supplied as an oval, white film coated tablet. Each tablet is debossed with \"AP 36\" on the scored side. Hexaflu® is supplied in bottles of 100 tablets (NDC 68220-0036-10). Dispense in a tight. light-resistant container. STORAGE: Store at controlled room temperature 20-25 o C (68-77 o F). Protect from light and moisture."],"id":"493d4c78-01d6-4385-8fc4-42f79bd62642","indications_and_usage":["INDICATIONS AND USAGE Hexaflu® tablets are indicated for the symptomatic relief of aches and pains and for the reduction of fever due to flu. Hexaflu® tablets are indicated for the symptomatic relief of nasal congestion and pressure, runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to the common cold, sinusitis, hay fever, and allergic rhinitis."],"information_for_patients":["Information for Patients May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness affect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your physician. Use caution when driving a motor vehicle or operating machinery."],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers Due to the possible passage 0 pseudoephedrine and dexchlorpheniramine into breast milk, and because of the higher than usual risk for infants fror sympathomimetic amines and antihistamines, the benefit to the mother vs. the potential risk should be considered and a decision should be made whether to discontinue nursing or to discontinue the drug."],"openfda":{},"overdosage":["OVERDOSAGE Keep Out of Reach of Children. In caae of accidental overdose, seek professional assistance or contact a Polson Control Center immedtately. Signs & Symptoms-May vary from CNS depression to stimulation (restlessness to convulsions). Atropine-like signs and symptoms may be prominent. Treatment-Induce vomiting if it has not occurred spontaneously. Precautions must be taken against aspiration especially in comatose patients. If gastric lavage is Indicated. isotonic or half-isotonic saline solution is preferred. Stimulants should not be used. If hypotension is a problem. vasopressor agents may be considered. In acute acetaminophen overdosage. dose-dependent, potentially fatal hepatic necrosis Is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma. and thrombocytopenia may also occur. In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams and fatalities with less than 15 grams. Importantly, young children seem to be more resistant than adults to the hepatotoxic effect of an acetaminophen overdose. Despite this. the measures outlined below should be initiated in any adult or child suspected of having ingested an acetaminophen overdose. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48-72 hours post-ingestion. The stomach should be emptied promptly by lavage or by induction of emesis with syrup of ipecac. Patients' estimates of the quantity of a drug ingested lire notoriously unreliable. Therefore, if an acetaminophen overdose is suspected, a serum acetaminophen assay should be obtained as early as possible. but no sooner than four hours following ingestion. Liver function studies should be obtained initially and repeated at 24 hour intervals. The antidote, N-acetylcysteine, should be administered as early as possible preferably within 16 hours of the overdose ingestion for optimal results, but in any case, within 24 hours. Following recovery, there are no residual, structural or functional hepatic abnormalities."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 6638 CL"],"pediatric_use":["Pediatric Use"],"precautions":["PRECAUTIONS General Information for Patients May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness affect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your physician. Use caution when driving a motor vehicle or operating machinery. Laboratory Tests Interactions Drug Interactions Do not use in patients receiving prescription monoamine oxidase inhibitor (MAO I) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If patients do not know if their prescription drug contains an MAOI, they should ask a doctor or pharmacist before taking this product. MAO inhibitors also prolong and intensify the anticholinergic effects of antihistamines. Sympathomimetics may reduce the antihypertensive effect of methyldopa, reserpine, veratrum alkaloids and mecamylamine. Alcohol and other sedative drugs will potentiate the sedative effects of dexchlorpheniramine. Care should be taken in administering this product concomitantly with other sympathomimetic amines since their combined effects or the cardiovascular system may be harmful to the patient. Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed with Hexaflu®. Pregnancy Pregnancy Category 6 1. As will any medication Hexaflu® should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Due to the possible passage 0 pseudoephedrine and dexchlorpheniramine into breast milk, and because of the higher than usual risk for infants fror sympathomimetic amines and antihistamines, the benefit to the mother vs. the potential risk should be considered and a decision should be made whether to discontinue nursing or to discontinue the drug. Pediatric Use Geriatric Use Patients 60 years and older are more likely t experience adverse reactions to sympathomimetics. Overdos may cause hallucinations, convulsions, CNS depression and death."],"pregnancy":["Pregnancy Pregnancy Category 6 1. As will any medication Hexaflu® should be given to a pregnant woman only if clearly needed. Teratogenic Effects Nonteratogenic Effects"],"set_id":"493d4c78-01d6-4385-8fc4-42f79bd62642","spl_product_data_elements":["HEXAFLU DEXCHLORPHENIRAMINE, PSEUDOEPHEDRINE, and ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE DEXCHLORPHENIRAMINE MALEATE DEXCHLORPHENIRAMINE DIBASIC CALCIUM PHOSPHATE DIHYDRATE STEARIC ACID SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE AP;36"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, patients should discontinue use and consult a physician. Patients should consult their physician if they have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland. Dexchlorpheniramine maleate should be used with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction. Due to its mild atropine-like action, dexchlorpheniramine maleate should be used cautiously in patients with bronchial asthma. Patients should not take this product, unless directed by their physician, if they have a breathing problem such as emphysema or chronic bronchitis, or if they have glaucoma. Antihistamines may diminish mental alertness. Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use, although reports of this event are rare. Reports almost invariably involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of acetaminophen."]}