{"active_ingredient":["Active Ingredients (in each 5 mL tsp) 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 EVERY 4 HOURS Adults and Children 12 years of age and over 5mL (1tsp) Children 6 years to under 12 years 2.5mL (1/2 tsp) Children under 6 years consult physician Children under 2 years do not use"],"dosage_and_administration_table":["<table width=\"100%\"><caption/><tbody><tr><td styleCode=\"Botrule Lrule Rrule Toprule\" rowspan=\"4\"><content styleCode=\"bold\">EVERY 4 HOURS </content></td><td styleCode=\"Botrule Lrule Rrule Toprule\">Adults and Children 12 years of age and over 5mL (1tsp)</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\">Children 6 years to under 12 years 2.5mL (1/2 tsp)</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\">Children under 6 years consult physician</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\">Children under 2 years do not use</td></tr></tbody></table>"],"effective_time":"20251114","id":"d5487434-8196-490e-90f9-ce09ce43c65d","inactive_ingredient":["Inactive ingredients : Citric acid, flavor, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, purified water and sucralose"],"indications_and_usage":["Uses: Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itchy nose or throat • runny nose • itchy, watery eyes • nasal congestion • temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants • temporarily restores freer breathing through 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":["Tussi Pres B"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["KRAMER NOVIS"],"package_ndc":["52083-237-01","52083-237-04","52083-237-16"],"product_ndc":["52083-237"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1148155"],"spl_id":["d5487434-8196-490e-90f9-ce09ce43c65d"],"spl_set_id":["d0afa44c-3acf-42a5-9889-4e9c10225256"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","BROMPHENIRAMINE MALEATE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","IXA7C9ZN03","04JA59TNSJ"],"upc":["0352083237164"]},"other_safety_information":["Other information : • Tamper evident: Do not use if inner seal is torn, broken or missing • Store at controlled room temperature 15°-30°C (59°-86°F) • Avoid excess heat or humidity"],"package_label_principal_display_panel":["Packaging image description"],"purpose":["Purposes Antihistamine Cough Suppressant Nasal Decongestant"],"set_id":"d0afa44c-3acf-42a5-9889-4e9c10225256","spl_product_data_elements":["Tussi Pres B dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN BROMPHENIRAMINE MALEATE BROMPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) 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 SACCHARIN FREE DYE FREE GRAPE FLAVOR Manufactured in the USA for Kramer Novis, San Juan, Puerto Rico 00917 Tel.787-767-2072 www.kramernovis.com"],"version":"5","warnings":["Warnings: Do not use • in a child under 2 years of age • 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 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 or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema. Do not give this product to children who have breathing problems such as chronic bronchitis or who have glaucoma without first consulting the child's doctor. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. While 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: • if you get nervous, dizzy or sleepless • new symptoms occur • symptoms do not get better within 7 days or are accompanied by fever • cough lasts 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."]}