{"active_ingredient":["ACTIVE INGREDIENT(S) Guaifenesin, USP 200 mg"],"ask_doctor":["ASK A DOCTOR BEFORE USE IF YOU HAVE cough that occurs with too much phlegm(mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema"],"dosage_and_administration":["DIRECTIONS shake well before using do not take more than 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product ml=milliliter this adult product is not intended for use in children under 12 years of age Age Dose adults & children 12 years & over 10 mL to 20 mL every 4 hours children under 12 years ask a doctor"],"dosage_and_administration_table":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\"><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\"><content styleCode=\"bold\">Age </content></td><td styleCode=\"Rrule\" valign=\"middle\"><content styleCode=\"bold\">Dose</content></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\"> adults &amp; children 12 years &amp; over</td><td styleCode=\"Rrule\" valign=\"middle\"> 10 mL to 20 mL every 4 hours</td></tr><tr><td styleCode=\"Lrule Rrule\" valign=\"middle\"> children under 12 years</td><td styleCode=\"Rrule\" valign=\"middle\"> ask a doctor</td></tr></tbody></table>"],"effective_time":"20240920","id":"d7fae410-9c1c-4231-9fde-2c51ad3d7e95","inactive_ingredient":["INACTIVE INGRADIENTS caramel color, citric acid anhydrous, FD&C red# 40 dye, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate."],"indications_and_usage":["USE(S) helps loosen phlegm(mucus) and thin bronchial secretions to drain bronchial tubes"],"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":["Leader Adult Tussin Mucus and Chest Congestion 541"],"generic_name":["GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["CARDINAL HEALTH 110, LLC. DBA LEADER"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["70000-0696-1","70000-0696-2"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["70000-0696"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1606850"],"spl_id":["d7fae410-9c1c-4231-9fde-2c51ad3d7e95"],"spl_set_id":["d7fae410-9c1c-4231-9fde-2c51ad3d7e95"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL LEADER TM NDC70000-0696-1 Adult Tussin Mucus + Chest Congestion Guaifenesin, USP 200 mg per 10 mL Expectorant Cherry Flavor For Ages 12 and Over Loosens and Relieves Mucus and Chest Congestion 100% Money Back Guarantee 4FL OZ(118 mL) LEADER TM NDC70000-0696-2 Adult Tussin Mucus + Chest Congestion Guaifenesin, USP 200 mg per 10 mL Expectorant Cherry Flavor For Ages 12 and Over Loosens and Relieves Mucus and Chest Congestion 100% Money Back Guarantee 8FL OZ (237 mL) 541-4oz-ldr-o.jpg 541-4oz-ldr-x.jpg 541-8oz-ldr-x.jpg 541-8oz-ldr-o.jpg"],"pregnancy_or_breast_feeding":["IF PREGNANT OR BREAST-FEEDING, ask a health professional before use."],"purpose":["PURPOSE Expectorant"],"questions":["QUESTIONS OR COMMENTS? (609) 860-2600"],"set_id":"d7fae410-9c1c-4231-9fde-2c51ad3d7e95","spl_product_data_elements":["Leader Adult Tussin Mucus and Chest Congestion 541 Guaifenesin GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN MENTHOL HIGH FRUCTOSE CORN SYRUP PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE CARAMEL"],"spl_unclassified_section":["OTHER INFORMATION each 10 mL contains: sodium 12 mg store at 20-25 o C(68-77 o F) protect from light"],"stop_use":["STOP USE AND ASK DOCTOR IF cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache."],"version":"1","warnings":["WARNINGS ."]}