{"adverse_reactions":["ADVERSE REACTIONS: Pyrilamine Maleate and Chlorpheniramine Maleate: Chlorpheniramine maleate may cause slight to moderate drowsiness relatively infrequently. Other possible side effects of antihistamines in general include: urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness or the mouth, nose and throat; cardiovascular effects (hypotension, headache, palpitation, tachycardia, extrasystoles); hematological effects (hemolytic anemia, thrombocytopenia, agranulocytosis); CNS disturbances (sedation, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions); gastrointestinal effects (epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation); genitourinary effects (urinary frequency, difficult urination, urinary retention, early menses) and respiratory effects (thickening of bronchial secretions, tightness of the chest, wheezing and nasal stuffiness). Phenylephrine Hydrochloride: Hyper-reactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea. Sympathomimetic amines 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. Phenylephrine may cause precordial pain, respiratory distress, tremor, weakness, hypertension, restlessness, anxiety, nervousness and dizziness."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies have been performed using Poly Hist PD to determine the long-term potential for carcinogenesis, mutagenesis and impairment of fertility. In a four-year evaluation of phenylephrine, no statistically significant associated between the drug and cancer was found."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY: Pyrilamine Maleate: Pyrilamine is an antihistamine belonging to the ethylenediamine class. Pyrilamine is a highly effective H 1 blocker which possesses local anesthetic activity. Pyrilamine antagonizes most of the smooth muscle stimulating actions of histamine on the H 1 receptors of the gastrointestinal tract, blood vessels and bronchial muscle. It also antagonizes the actions of histamine that result in increased capillary permeability and the formation of edema. Pyrilamine has a duration of action of 4 to 6 hours in clinical studies. Chlorpheniramine Maleate: Chlorpheniramine is an antihistamine belonging to the alkylamine class. It possesses anticholinergic and sedative effects. Antihistamines appear to compete with histamine for H 1 cell receptor sites on effector cells. Chlorpheniramine Maleate does not prevent the release of histamine in response to injury, drugs or antigens. Antihistamines effectively block most smooth muscle responses to histamine and acts as an antagonist of the constrictor action of histamine on respiratory smooth muscle. Antihistamines counteract edema formation and whealing in response to injury, antigens, or histamine-liberating drugs. Chlorpheniramine is readily absorbed from the gastrointestinal tract and has a duration of 4 to 6 hours. Plasma half-life is approximately 22 hours. Degradation products of chlorpheniramine's metabolic transformation by the liver are almost completely excreted in 24 hours via the kidney. The alkylamines of which chlorpheniramine is the prototype, are among the most potent H 1 blockers. Although not so prone as others to cause drowsiness, a significant proportion of patients do experience this effect. CNS stimulation is more common in chlorpheniramine than in other groups of H 1 blockers. Phenylephrine Hydrochloride: Phenylephrine is a potent postsynaptic alpha-receptor agonist with little effect on beta-receptors on the heart. Phenylephrine has no effect on 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 is due to its ability to release norepinephrine. Therapeutic doses of phenylephrine mainly 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. Following oral administration of phenylephrine, constriction of blood vessels in the nasal mucosa relieves nasal congestion associated with allergy or head colds. Following oral administration of phenylephrine, nasal decongestion may occur within 15 to 20 minutes and may persist for up to 4 hours. Phenylephrine is irregularly absorbed from and readily metabolized in the gastrointestinal tract. Phenylephrine is metabolized in the liver and intestine by monoamine oxidase. The metabolites and their route and rate of excretion have not been identified. The pharmacologic action of phenylephrine is terminated at least partially by uptake of the drug into the tissues."],"contraindications":["CONTRAINDICATIONS: Hypersensitivity to any of the ingredients. Patients known to be sensitive to other sympathomimetic amines may exhibit cross sensitivity with this drug. Poly Hist PD is contraindicated in patients with severe hypertension, severe coronary artery disease and patients on monoamine oxidase (MAO) inhibitor therapy. It is also contraindicated in patients with diabetes or hyperthyroidism. Antihistamines should not be administered to premature or newborn infants or be used to treat lower respiratory tract symptoms or asthma."],"description":["POLY HIST PD Antihistamine / Decongestant Sugar Free / Alcohol Free / Dye Free DESCRIPTION: POLY HIST PD is a sugar free, alcohol free, dye free, clear and colorless liquid with a bubble gum odor and flavor. Each 5 mL (1 teaspoonful) contains: Pyrilamine Maleate.................... 12.5 mg Chlorpheniramine Maleate........... 2 mg Phenylephrine HCl...................... 7.5 mg Pyrilamine Maleate is an antihistamine that occurs as a white crystalline powder, usually having a faint odor. It is very soluble in water, freely soluble in alcohol and chloroform, and slightly soluble in ether and benzene. The chemical name is 1,2-Ethanediamine, N-[(4-methoxyphenyl)methyl]-N', N'dimethyl-N-2-pyridinyl-, (Z)-2- butenedioate (1:1). Its structural formula is as follows: Chlorpheniramine Maleate is an antihistaminic that occurs as a white, odorless crystalline powder. Its solutions have a pH between 4 and 5. It is freely soluble in water, soluble in alcohol and chloroform, and slightly soluble in ether and benzene. The chemical name is 2-Pyridinepropanamine, gamma-(4-chlorophenyl)-N,N-dimethyl-, (Z)-2-butenedioate (1:1). Its structural formula is as follows: Phenylephrine hydrochloride is an adrenergic that occurs as white or practically white, odorless crystals, having a bitter taste. It is freely soluble in water and alcohol. It is affected by light. The chemical name is benzenemethanol, 3-hydroxy-alpha[(methylamino)methyl]-, hydrochloride (R)-. Its structural formula is as follows: Inactive ingredients: Propylene glycol, sorbitol, glycerin, sodium saccharin, purified water, and bubble gum flavoring. Pyrilamine Maleate Chemical Structure Chlorpheniramine Maleate Chemical Structure Phenylephrine Hydrochloride Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Adults and Children 12 years of age and over: 1-2 teaspoonfuls every 4-6 hours. Children 6 to under 12 years of age: 1/2 teaspoonful every 4-6 hours. Not recommended for Children under 6 years of age."],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions: MAO inhibitors and tricyclic antidepressants may prolong and intensify the anticholinergic (drying) effects of antihistamines. Beta-adrenergic blockers and MAO inhibitors may potentiate the pressor effect of phenylephrine. Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Concurrent use of tricyclic antidepressants may antagonize the effects of phenylephrine. Concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates, and other CNS depressants may have an additive effect."],"effective_time":"20170808","geriatric_use":["Geriatric Use: The elderly (60 years and older) are more likely to experience adverse reactions from sympathomimetics and antihistamines. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death."],"how_supplied":["HOW SUPPLIED: 16 fluid ounce bottles, NDC 50991-405-16 and 20 mL bottles, NDC 50991-405-20. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, CONTACT A POISON CONTROL CENTER OR SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY."],"id":"5649ad9f-14c7-5e65-e054-00144ff88e88","indications_and_usage":["INDICATIONS AND USAGE: Poly Hist PD is indicated for symptomatic relief of seasonal and perennial allergic rhinitis, and vasomotor rhinitis."],"information_for_patients":["Information for Patients: Antihistamines may impair the mental and physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery. Patients should also be warned about possible additive effects with alcohol and other central nervous system depressants (hypnotics, sedatives and tranquilizers)."],"labor_and_delivery":["Labor and Delivery: Administration of phenylephrine to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractility of the uterus and decreasing uterine blood flow."],"nursing_mothers":["Nursing Mothers: Due to the possible passage of antihistamines into breast milk, and because of the higher than usual risk for infants from sympathomimetic amines and antihistamines, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of both."],"openfda":{},"overdosage":["OVERDOSAGE: Signs and symptoms: Pyrilamine Maleate and Chlorpheniramine Maleate: Manifestations of antihistamine overdosage may vary from central nervous system depression (sedation, apnea, cardiovascular collapse) to stimulation (insomnia, hallucinations, tremors or convulsions). 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 dilated pupils, flushing, hypothermia and gastrointestinal symptoms. Phenylephrine Hydrochloride: May cause hypertension, headache, convulsions, cerebral hemorrhage and vomiting. Ventricular premature 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 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, hallucination, convulsions or delirium but in some individuals, there may be CNS depression with somnolence, stupor or respiratory depression. Arrhythmias (including ventricular fibrillation) may lead to hypotension and circulatory collapse. Severe hypokalemia can occur, probably due to compartmental shift rather than a depletion of potassium. Treatment: The patient should be induced to vomit even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac is facilitated by physical activity and by the administration of eight to twelve ounces of water. If emesis does not occur within fifteen minutes, the dose of ipecac should be repeated. 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. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed. Isotonic and one-half isotonic saline are the lavage solution of choice. Saline cathartics, such as milk of magnesia, draw water into the bowel by osmosis and therefore, may be valuable for their action in rapid dilution of bowel content. After emergency treatment, the patient should continue to be medically monitored. Treatment of the signs and symptoms of overdosage is symptomatic and supportive."],"package_label_principal_display_panel":["PRODUCT PACKAGING: The packaging below represents the labeling currently used: Principal Display Panel and Side Panel for 473 mL Label: NDC 50991-405-16 POLY HIST PD EACH TEASPOONFUL (5 mL) FOR ORAL ADIMISTRATION CONTAINS: PYRILAMINE MALEATE..................12.5 mg CHLORPHENIRAMINE MALEATE...... 2 mg PHENYLEPHRINE HCl......................7.5 mg SUGAR FREE ALCOHOL FREE DYE FREE Rx Only 16 fl oz (473 mL) DOSAGE AND ADMINISTRATION: Adults and Children 12 years of age and over: 1-2 teaspoonfuls every 4-6 hours. Children 6 to under 12 years of age: 1/2 teaspoonful every 4-6 hours. Not recommended for Children under 6 years of age. SEE LABEL FOLDOUT FOR FULL PRESCRIBING INFORMATION. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Store at controlled room temperature, 15 o -30 o C (59 o -86 o F). Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. This bottle is not to be dispensed to consumer. Tamper evident by heat seal under cap. Do not use if there is evidence of tampering. POLY HIST PD is a product of POLY PHARMACEUTICALS, INC. Mfg. by: Great Southern Labroatories, Houston, TX 77099 Distributed by: Poly Pharmaceuticals, Inc. Mobile, AL 36619 Rev. 11/09 Poly Hist PD Packaging Poly Hist PD Packaging Poly Hist PD Packaging"],"pediatric_use":["Pediatric Use: In infants and children especially, antihistamines in overdosage may cause hallucination, convulsions or death. As in adults, antihistamines may diminish mental alertness in children. In the young child particularly, they may produce excitation."],"precautions":["PRECAUTIONS: General: Antihistamines have an atropine-like action and therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension. Phenylephrine should be used with caution in patients with diabetes, hypertension, cardiovascular disease and hyper-reactivity to ephedrine."],"pregnancy":["Usage in Pregnancy: Pregnancy Category C: Moderate overexposure to phenylephrine has been found to contribute to birth defects in rabbits. Animal reproduction studies have not been conducted with the other ingredients in Poly Hist PD. Poly Hist PD should be used during pregnancy only if the potential benefit justifies the possible risk to the fetus."],"set_id":"8728160d-6172-4f4e-b512-46f5d9bca733","spl_product_data_elements":["POLY HIST PD Pyrilamine Maleate, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride PYRILAMINE MALEATE PYRILAMINE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"],"storage_and_handling":["Storage: Store at controlled room temperature, 15 o -30 o C (59 o -86 o F). DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER WITH A CHILD-RESISTANT CLOSURE AS DESCRIBED IN THE USP/NF. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. Manufactured by: Great Southern Laboratories, Houston, TX 77099 Distributed by: Poly Pharmaceuticals, Inc., Mobile, AL 36619 Rev. 11/09"],"version":"2","warnings":["WARNINGS: Pyrilamine Maleate and Chlorpheniramine Maleate: Antihistamines should be used with considerable caution in patients with narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction. In infants and children especially, antihistamine overdosage may cause hallucinations, convulsions or death. As in adults, antihistamines may diminish mental alertness in children. Chlorpheniramine Maleate has additional effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers) Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating appliances, machinery, etc. Phenylephrine Hydrochloride: Sympathomimetic amines should be used with considerable 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. Hypertensive crisis could occur with concurrent use of phenylephrine and monoamine oxidase (MAO) inhibitors, indomethacin or with beta blockers and methyldopa. If a hypertensive crisis occurs, this drug should be discontinued immediately and therapy to lower blood pressure should be instituted. Fever should be managed by means of external cooling. The elderly (approximately sixty years or older) are more likely to have adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death. Therefore, safe use of a short-acting sympathomimetic should be demonstrated in the individual elderly patient before considering the use of a sustained-release formulation. Discontinue use if adverse reaction(s) occur."]}