{"active_ingredient":["Active ingredient (in each 10 mL) Guaifenesin, 400 mg"],"ask_doctor":["Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema"],"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 adults and children 12 years and over 10 mL every 4 hours children 6 to under 12 years of age 5 mL every 4 hours children 4 to under 6 years of age 2.5 mL every 4 hours children under 4 years of age Consult a doctor"],"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\">adults and children 12 years and over</td><td align=\"left\" styleCode=\"Lrule Botrule\" valign=\"top\">10 mL every 4 hours</td></tr><tr ID=\"id_8980b4eb-911a-4618-b01b-22b600aafc62\"><td align=\"left\" styleCode=\"Botrule Rrule\" valign=\"top\">children 6 to under 12 years of age</td><td align=\"left\" styleCode=\"Lrule Botrule\" valign=\"top\">5 mL every 4 hours</td></tr><tr ID=\"id_8787465f-53a3-4a14-a93e-7de62326c591\"><td align=\"left\" styleCode=\"Botrule Rrule\" valign=\"top\">children 4 to under 6 years of age</td><td align=\"left\" styleCode=\"Lrule Botrule\" valign=\"top\">2.5 mL every 4 hours</td></tr><tr ID=\"id_3994268f-5c8d-4c73-b110-f341d797b0c8\"><td align=\"left\" styleCode=\"Rrule\" valign=\"top\">children under 4 years of age</td><td align=\"left\" styleCode=\"Botrule\" valign=\"top\">Consult a doctor</td></tr></tbody></table>"],"effective_time":"20251009","id":"40b8ef34-8eeb-c72d-e063-6294a90aff26","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":["Giltuss EX Expectorant"],"generic_name":["GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Gil Pharmaceutical Corp"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["58552-145-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["58552-145"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310625"],"spl_id":["40b8ef34-8eeb-c72d-e063-6294a90aff26"],"spl_set_id":["a8c53c14-ba82-2c68-e053-2a95a90a9894"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"package_label_principal_display_panel":["MAXIMUM STRENGTH Giltuss® EX EXPECTORANT ALCOHOL FREE. SUGAR FREE. DYE FREE. NON-DROWSY RELIEVES CHEST CONGESTION LOOSENS AND LIQUIFIES PHLEGM LIQUIFIES AND REMOVE MUCUS HELPS TO EXPEL PHLEGM IN CHEST AND THROAT TUTTI FRUTTI FLAVOR 4FL OZ (118 mL) 58552-145"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"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":"a8c53c14-ba82-2c68-e053-2a95a90a9894","spl_product_data_elements":["Giltuss EX Expectorant Guaifenesin POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM CITRATE WATER GLYCERIN SUCRALOSE ANHYDROUS CITRIC ACID 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 cough 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 you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough 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. 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."]}