{"active_ingredient":["Active Ingredients (in each 5 mL teaspoonful) Brompheniramine Maleate 4 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg"],"dosage_and_administration":["​Directions • do not take more than 6 doses in any 24-hour period. • mL = milliliter, tsp = teaspoon adults and children 12 years of age and over 5 mL (1 tsp) every 4 hours children 6 to under 12 years of age 2.5 mL (½ tsp) every 4 hours children under 6 years of age do not use"],"dosage_and_administration_table":["<table width=\"50%\"><caption/><tbody><tr><td styleCode=\"Rrule Toprule Botrule\">adults and children 12 years of age and over</td><td styleCode=\"Lrule Toprule Botrule\"> 5 mL (1 tsp) every 4 hours</td></tr><tr><td styleCode=\"Rrule Toprule Botrule\">children 6 to under 12 years of age</td><td styleCode=\"Lrule Toprule Botrule\"> 2.5 mL (&#xBD; tsp) every 4 hours</td></tr><tr><td styleCode=\"Rrule Toprule Botrule\">children under 6 years of age</td><td styleCode=\"Lrule Toprule Botrule\"> do not use</td></tr></tbody></table>"],"effective_time":"20251203","id":"0e6e64a1-f9ee-47cb-8ee7-23800b7fb564","inactive_ingredient":["Inactive ingredients citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sucralose."],"indications_and_usage":["Uses • temporarily relieves: • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever or other upper respiratory allergies • temporarily controls cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants • temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies • temporarily restores freer breathing through the nose"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["Presgen B"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["KRAMER NOVIS"],"package_ndc":["52083-637-16"],"product_ndc":["52083-637"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1148155"],"spl_id":["0e6e64a1-f9ee-47cb-8ee7-23800b7fb564"],"spl_set_id":["5befa829-32bd-4978-8a0e-1d6513ff37a4"],"substance_name":["BROMPHENIRAMINE MALEATE","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["IXA7C9ZN03","9D2RTI9KYH","04JA59TNSJ"],"upc":["0352083637162"]},"package_label_principal_display_panel":["Packaging PresgenB"],"purpose":["Purposes Antihistamine Cough suppressant Nasal decongestant"],"questions":["Questions or comments? 1-787-767-2072 ​You may also report serious side effects to this phone number. Call weekdays from 8 AM to 4 PM AST"],"set_id":"5befa829-32bd-4978-8a0e-1d6513ff37a4","spl_product_data_elements":["Presgen B dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride BROMPHENIRAMINE MALEATE BROMPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SUCRALOSE SWEET GRAPE"],"spl_unclassified_section":["Drug Facts","Brompheniramine Maleate ANTIHISTAMINE Dextromethorphan HBr COUGH SUPPRESSANT Phenylephrine HCl NASAL DECONGESTANT SUGAR AND ALCOHOL FREE SACCHARINE FREE DYE FREE Compare to Tussi-Press ® ​B GRAPE FLAVOR Kramer Novis Pharmaceuticals within reach of patients ​ Manufactured for Kramer Novis San Juan, PR 00917 www.kramernovis.com Manufactured in the USA with imported ingredients"],"storage_and_handling":["Other information • tamper evident feature: do not use if security seal is torn, broken or missing. • store at controlled room temperature 15-30°C (59-86°F). • avoid excessive heat or humidity."],"version":"5","warnings":["Warnings Do not use if you are now taking 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. Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis • chronic cough that lasts such as occurs with smoking, asthma, or emphysema. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product • do not exceed recommended dosage • excitability may occur, especially in children • drowsiness may occur; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery. Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • new symptoms occur • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of serious conditions. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."]}