{"active_ingredient":["Active ingredients (in each 5 mL) Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 100 mg"],"ask_doctor":["Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma"],"do_not_use":["Do not use in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product."],"dosage_and_administration":["Directions SHAKE WELL BEFORE EACH USE do not give more than 6 doses in any 24-hour period use only with enclosed dose cup. Do not use with any other dosing device. mL = milliliter children 6 to under 12 years 5 mL - 10 mL every 4 hours children 4 to under 6 years 2.5 mL - 5 mL every 4 hours children under 4 years do not use"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>children 6 to under 12 years</td><td>5 mL - 10 mL every 4 hours</td></tr><tr><td>children 4 to under 6 years</td><td>2.5 mL - 5 mL every 4 hours</td></tr><tr><td>children under 4 years</td><td><content styleCode=\"bold\">do not use</content></td></tr></tbody></table>"],"effective_time":"20260528","id":"52ea129f-f95c-b9a3-e063-6394a90ac0be","inactive_ingredient":["Inactive ingredients agave syrup (organic), blueberry flavor (organic), flavors (natural), purified water"],"indications_and_usage":["Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive"],"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. (1-800-222-1222)"],"openfda":{"application_number":["M012"],"brand_name":["Kids Cough and Chest Congestion"],"generic_name":["DEXTROMETHORPHAN HBR, GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Genexa Inc."],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["69676-0037-9"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["69676-0037"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["52ea129f-f95c-b9a3-e063-6394a90ac0be"],"spl_set_id":["a7ab2140-de09-158f-e053-2a95a90a25a0"],"substance_name":["GUAIFENESIN","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["495W7451VQ","9D2RTI9KYH"],"upc":["0850015736018"]},"package_label_principal_display_panel":["Genexa ® CLEAN MEDICINE Kids' DAYTIME Cough & Chest Congestion Ages 4-11 Dextromethorphan HBr - Cough Suppressant Guaifenesin - Expectorant Cough Mucus Chest Congestion 0% Artificial Additives, Dyes, Artificial Sweeteners, Common Allergens Made with Real Agave + Blueberry Flavoring 4 FL OZ (118 mL) 153A_carton R-20251226"],"purpose":["Purposes Cough suppressant Expectorant"],"questions":["Questions? 1-855-436-3921"],"recent_major_changes":["Directions SHAKE WELL BEFORE EACH USE do not give more than 6 doses in any 24-hour period use only with enclosed dose cup. Do not use with any other dosing device. mL = milliliter children 6 to under 12 years 5 mL - 10 mL every 4 hours children 4 to under 6 years 2.5 mL - 5 mL every 4 hours children under 4 years do not use"],"recent_major_changes_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>children 6 to under 12 years</td><td><paragraph>5 mL - 10 mL</paragraph><paragraph>every 4 hours</paragraph></td></tr><tr><td>children 4 to under 6 years</td><td><paragraph>2.5 mL - 5 mL</paragraph><paragraph>every 4 hours</paragraph></td></tr><tr><td>children under 4 years</td><td><content styleCode=\"bold\">do not use</content></td></tr></tbody></table>"],"set_id":"a7ab2140-de09-158f-e053-2a95a90a25a0","spl_product_data_elements":["Kids Cough and Chest Congestion Dextromethorphan HBr, Guaifenesin AGAVE TEQUILANA JUICE GUAIFENESIN GUAIFENESIN WATER DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN BLUEBERRY Light"],"spl_unclassified_section":["Drug Facts","SHAKE WELL BEFORE EACH USE DO NOT use if perforated band around the bottle is disturbed or missing. U.S. Patent No. 11,931,413 Distributed by: Genexa Inc. Atlanta, GA 30324 | genexa.com","Made in the USA with globally sourced ingredients NDC 69676-0037-9"],"stop_use":["Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition."],"storage_and_handling":["Other information store between 20-25°C (68-77°F)"],"version":"12","warnings":["Warnings Do not use in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"]}