{"active_ingredient":["Active ingredients (in each 5mL tsp) Chlorpheniramine Maleate, 2 mg Dextromethorphan HBr, 10 mg Phenylephrine HCl, 5 mg"],"dosage_and_administration":["Directions • Do not exceed 6 doses in 24 hours. Adults and children 12 years of age and older 2 teaspoonfuls (10 mL) every 4 hours. Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4 hours. Children 2 to under 6 years of age Ask a doctor."],"dosage_and_administration_table":["<table width=\"40%\"><caption/><tbody><tr><td styleCode=\"Rrule Botrule\">Adults and children 12 years of age and older</td><td styleCode=\"Lrule Botrule\">2 teaspoonfuls (10 mL) every 4 hours. </td></tr><tr><td styleCode=\"Rrule Botrule\">Children 6 to under 12 years of age</td><td styleCode=\"Lrule Botrule\">1 teaspoonful (5 mL) every 4 hours.</td></tr><tr><td styleCode=\"Rrule Botrule\">Children 2 to under 6 years of age </td><td styleCode=\"Lrule Botrule\">Ask a doctor.</td></tr></tbody></table>"],"effective_time":"20251204","id":"8a52f9ca-43f9-4f88-ae67-2ee6e1541d51","inactive_ingredient":["Inactive Ingredients citric acid, flavor, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucrose."],"indications_and_usage":["Uses • For the temporary relief of runny nose, sneezing, itching of the nose or throat and itchy, watery eyes due to hay fever. • Temporarily relieves cough due to minor throat and bronchial irritation occurring with the common cold. • Temporarily restores freer breathing through the nose."],"keep_out_of_reach_of_children":["Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately."],"openfda":{"application_number":["M012"],"brand_name":["GENCONTUSS"],"generic_name":["CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["KRAMER NOVIS"],"package_ndc":["52083-650-16"],"product_ndc":["52083-650"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1363752"],"spl_id":["8a52f9ca-43f9-4f88-ae67-2ee6e1541d51"],"spl_set_id":["69d16d25-b09b-430e-8e01-0962d840dc21"],"substance_name":["CHLORPHENIRAMINE MALEATE","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["V1Q0O9OJ9Z","9D2RTI9KYH","04JA59TNSJ"],"upc":["0352083650161"]},"package_label_principal_display_panel":["Packaging GENCONTUSS"],"purpose":["Purposes Antihistamine Cough suppressant Nasal decongestant"],"questions":["Questions or comments? call weekdays from 8 AM to 4 PM AST at 1.787.767.2072"],"set_id":"69d16d25-b09b-430e-8e01-0962d840dc21","spl_product_data_elements":["GENCONTUSS CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCROSE Clear Red"],"spl_unclassified_section":["Drug Facts","ANTIHISTAMINE Chlorpheniramine Maleate COUGH SUPPRESSANT Dextromethorphan Hbr NASAL DECONGESTANT Phenylephrine Hcl Cherry Flavor Kramer Novis Pharmaceuticals within reach of patients Manufactured in the USA for Kramer Novis San Juan, PR 00917 www.kramernovis.com"],"storage_and_handling":["Other information • Tamper evident feature: Do not use if inner seal is torn, broken or missing. • Store at controlled room temperature 15-30⁰C(59-86⁰F). • Avoid excessive heat or humidity."],"version":"7","warnings":["Warnings : Do not use • to sedate a child or to make a child sleepy. • If you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric or emotional condition) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a 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 • difficulty in urination due to enlargement of the prostate gland • cough that occurs with too much phlegm (mucus) • breathing problems or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis 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 • drowsiness may occur • avoid alcoholic beverages • alcohol, sedatives and tranquilizers may increase the drowsiness effect • use caution when driving a motor vehicle or operating machinery. Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • excitability occurs, especially in children • symptoms do not improve within 7 days or are accompanied by fever • cough persists for more than 1 week tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately."]}