{"adverse_reactions":["ADVERSE REACTIONS Sympathomimetic amines may cause convulsions, CNS stimulation, cardiac arrhythmias, respiratory difficulty, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, weakness, pallor and dysuria. Antihistamines may cause sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria and, rarely, excitability in children. Symptoms No information is available as to specific results of an overdose of BP Allergy Junior Suspension. However, signs and symptoms may vary from CNS depression to stimulation (restlessness to convulsions). Atropine-like signs and symptoms may be prominent. Overdosage in young children may lead to convulsions and death in severe cases. Treatment Induce vomiting if it has not occurred spontaneously. Precautions must be taken against aspiration especially in infants, children and 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."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY BP Allergy Junior Suspension combines the sympathomimetic decongestant effect of phenylephrine with the antihistaminic action of chlorpheniramine. Phenylephrine acts predominantly by a direct action on alpha adrenergic receptors. In therapeutic doses, the drug has no significant stimulant effect on the beta adrenergic receptors of the heart and causes little, if any, central nervous system stimulation. Following oral administration, constriction of blood vessels in the nasal mucosa may relieve nasal congestion. Chlorpheniramine competitively antagonizes most of the smooth muscle stimulating actions of histamine on the H 1 , receptors of the GI 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."],"contraindications":["CONTRAINDICATIONS BP Allergy Junior Suspension is contraindicated in patients with hypersensitivity to any of its ingredients, antihistamines of similar structure, or sympathomimetics. Also contraindicated in nursing mothers, patients with narrow-angle glaucoma, urinary retention, peptic ulcer, severe hypertension, coronary artery disease, or in patients with breathing problems such as emphysema or chronic bronchitis. Do not use in patients receiving MAO inhibitors (see PRECAUTIONS: Drug Interactions) . Antihistamines should not be used to treat lower respiratory tract conditions including asthma."],"description":["DESCRIPTION BP Allergy Junior Suspension is a nasal decongestant/antihistamine in a bubblegum flavored, homogeneous suspension for oral administration. Each 5 mL (1 teaspoonful) contains: Phenylephrine Tannate ...........................................................20 mg Chlorpheniramine Tannate ....................................................... 4mg Inactive ingredients: Antifoarn Emulsion, aspartame, bubble gum flavor, citric acid, D&C Yellow #10, FD&C Red #40, glycerin, magnesium aluminum silicate, methyl paraben, propylene glycol, prosweet, purified water, sodium benzoate, sodium saccharin, sorbitol, xanthan gum. Phenylephrine Tannate is a decongestant. The chemical name for Phenylephrine is (-)-m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol. Its structure is as follows: Chlorpheniramine Tannate is an antihistamine. The chemical name for Chlorpheniramine is: 2-[p-Chloro-α [2- (dimethylamino)ethyl]benzyl]pyridine. Its structure is as follows: Chemical Structure Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children over 12 years of age: 2 teaspoonfuls every 12 hours. Children 6 to under 12 years of age: 1 teaspoonful every 12 hours. Children 2 to under 6 years of age: 1/2 teaspoonful every 12 hours. Do not exceed 2 doses during a 24-hour period. Shake bottle before use. See accompanying literature for full prescribing information. NOTE: The tannate salts of phenylephrine and chlorpheniramine have much higher molecular weights than the corresponding salts of the active base compounds; therefore, even though the dosage (by milligram weight) of the tannate salt may seem high, the proportion of phenylephrine and chlorpheniramine in the tannate salts approach those in the corresponding hydrochloride and maleate salts. The percentage of phenylephrine in phenylephrine tannate is approximately 29% while in phenylephrine hydrochloride the phenylephrine is approximately 82%. Similarly, the percentage of the chlorpheniramine in chlorpheniramine maleate is approximately 70%."],"drug_interactions":["Drug Interactions Do not use in patients receiving a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. MAO inhibitors also prolong and intensify the antcholinergic 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 chlorpheniramine. Care should be taken in administering this product concomitantly with other sympathomimetic amines since their combined effects on the cardiovascular system may be harmful to the patient."],"effective_time":"20180522","geriatric_use":["Geriatric Usage Use with caution in patients older than 60 years of age. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy."],"how_supplied":["HOW SUPPLIED BP Allergy Junior Suspension, each teaspoonful (5mL) of which contains Phenylephrine Tannate, 20 mg and Chlorpheniramine Tannate, 4 mg is supplied a bubblegum flavored, non-alcohol suspension in bottles of 16 oz (473 mL), NDC 42192-502-16."],"id":"8141c768-3d60-455b-a046-f87dc14868bf","indications_and_usage":["INDICATIONS AND USAGE BP Allergy Junior Suspension is indicated for the relief of upper respiratory symptoms associated with allergies and the common cold, such as: nasal congestion, sinusitis, sneezing, lacrimation, vasomotor rhinitis, pos-nasal drip, and hay fever."],"nursing_mothers":["Nursing Mothers Because of the potential for serious adverse reactions in nursing infants from BP Allergy Junior Suspension, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 42192-502-16 BP Allergy Junior Suspension Nasal Decongestant Antihistamine Each 5 mL (teaspoonful) contains: Phenylephrine Tannate.................................. 20 mg Chlorpheniramine Tannate.............................. 4 mg Rx Only SHAKE WELL BROOKSTONE PHARMACEUTICALS, LLC 16 fl oz (473 mL) PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label"],"pediatric_use":["Pediatric Usage Safety and effectiveness of BP Allergy Junior Suspension in children under the age of 2 have not been established."],"precautions":["PRECAUTIONS Phenylketonurics: Contains Phenylalanine: 5.0 mg / 5 mL. Information for Patients: May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your physician. Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly."],"pregnancy":["Usage in Pregnancy Pregnancy Category C: Animal reproduction studies have not been conducted with BP Allergy Junior Suspension. It is also not known whether BP Allergy Junior Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. BP Allergy Junior Suspension should be given to a pregnant woman only if clearly needed."],"set_id":"9dbc6d1a-8612-41ed-8560-8ba50733e0ea","spl_product_data_elements":["BP Allergy Junior Suspension PHENYLEPHRINE TANNATE, CHLORPHENIRAMINE TANNATE ASPARTAME NEATSFOOT OIL CITRIC ACID MONOHYDRATE D&C YELLOW NO. 10 FD&C RED NO. 40 GLYCERIN MAGNESIUM ALUMINUM SILICATE METHYLPARABEN PROPYLENE GLYCOL WATER SODIUM BENZOATE SACCHARIN SODIUM SORBITOL XANTHAN GUM PHENYLEPHRINE TANNATE PHENYLEPHRINE CHLORPHENIRAMINE TANNATE CHLORPHENIRAMINE"],"spl_unclassified_section":["Rx Only"],"storage_and_handling":["Storage Store at Controlled Room Temperature 25 C (77 F); excursions permitted to 15 - 30 C (59 - 86 F) [See USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light- resistant container with a child-resistant closure as defined in the USP/NF. WARNING: Phenylketonurics: Contains Phenylalanine: 5.0 mg/5 mL. 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 Rx Only Manufactured for: Brookstone Pharmaceuticals, LLC 9005 Westside Parkway Alpharetta, GA 30004 Iss. 12/07"],"version":"1","warnings":["WARNINGS Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a physician. If symptoms do not improve within 7 days or are accompanied by fever, consult a physician. Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with possibility of convulsion or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions. Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery, and may impair mental alertness in children. Chlorpheniramine has an atropine-like action and should be used with caution in patients with increased intraocular pressure, cardiovascular disease, hypertension or in patients with a history of bronchial asthma. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and sometimes death."]}