{"active_ingredient":["Active ingredients (in each 5 mL) Guaifenesin, 200 mg"],"ask_doctor":["Ask a doctor before use if your child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma or chronic bronchitis"],"dosage_and_administration":["Directions do not take more than 6 doses in any 24-hour period use enclosed dosing cup keep dosage cup for use with this product ml = milliliters children under 4 years Consult a doctor children 4 to under 6 years 2.5 mL every 4 hours children 6 to under 12 years 5 mL every 4 hours children 12 years and over 10 mL every 4 hours"],"dosage_and_administration_table":["<table width=\"0.000\" ID=\"id_d517beb3-612c-42ce-8773-f22dcf7d8d1a\"><col/><col/><tbody><tr ID=\"id_f0502eac-d23f-4ac0-b04f-cddd93cc67be\"><td align=\"left\" styleCode=\"Botrule Rrule\" valign=\"top\">children under 4 years</td><td align=\"left\" styleCode=\"Lrule Botrule\" valign=\"top\">Consult a doctor</td></tr><tr ID=\"id_8980b4eb-911a-4618-b01b-22b600aafc62\"><td align=\"left\" styleCode=\"Botrule Rrule\" valign=\"top\">children 4 to under 6 years</td><td align=\"left\" styleCode=\"Lrule Botrule\" valign=\"top\">2.5 mL every 4 hours</td></tr><tr ID=\"id_8787465f-53a3-4a14-a93e-7de62326c591\"><td align=\"left\" styleCode=\"Botrule Rrule\" valign=\"top\">children 6 to under 12 years</td><td align=\"left\" styleCode=\"Lrule Botrule\" valign=\"top\">5 mL every 4 hours</td></tr><tr ID=\"id_3994268f-5c8d-4c73-b110-f341d797b0c8\"><td align=\"left\" styleCode=\"Rrule\" valign=\"top\">children 12 years and over</td><td align=\"left\" styleCode=\"Botrule\" valign=\"top\">10 mL every 4 hours</td></tr></tbody></table>"],"effective_time":"20251009","id":"40b92b1e-3784-2ed2-e063-6394a90a8737","inactive_ingredient":["Inactive ingredients citric acid, glycerin, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose."],"indications_and_usage":["Uses 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."],"openfda":{"application_number":["M012"],"brand_name":["Childrens Giltuss EX Expectorant"],"generic_name":["GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Gil Pharmaceutical Corp"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["58552-146-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["58552-146"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310625"],"spl_id":["40b92b1e-3784-2ed2-e063-6394a90a8737"],"spl_set_id":["a8c59e6d-c11c-2664-e053-2a95a90a8333"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"package_label_principal_display_panel":["Children 4-12 Children's Giltuss® EX EXPECTORANT Alcohol Free, Sugar Free. Dye Free, Non Drowsy CHEST CONGESTION LIQUIFIES AND LOOSENS PHLEGM LIQUIFIES AND REMOVES MUCUS TUTTI FRUTTI FLAVOR 4FL OZ (118 mL) 58552-146 Expectorant Children"],"purpose":["Purpose Expectorant"],"questions":["Questions or comments? Call 1-787-848-9114 , Monday-Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects."],"set_id":"a8c59e6d-c11c-2664-e053-2a95a90a8333","spl_product_data_elements":["Childrens Giltuss EX Expectorant Guaifenesin WATER GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED SUCRALOSE ANHYDROUS CITRIC ACID SODIUM CITRATE METHYLPARABEN PROPYLPARABEN GUAIFENESIN GUAIFENESIN"],"spl_unclassified_section":["Drug Facts","Tamper Evident: do not use if safety seal is broken or missing. MANUFACTURED FOR GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00717-1565 giltuss.com"],"stop_use":["Stop use and ask a doctor if the child has a cough that lasts for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition."],"storage_and_handling":["Other information store at room temperature 15°-30°C (59°-86°F) close cap tightly SAVE CARTON FOR COMPLETE DRUG FACTS"],"version":"6","warnings":["Warnings Ask a doctor before use if your child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma or chronic bronchitis Stop use and ask a doctor if the child has a cough that lasts for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign 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."]}