{"active_ingredient":["ACTIVE INGREDIENTS (in each 5 mL) Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg"],"ask_doctor":["ASK A DOCTOR BEFORE USE IF THE CHILD HAS heart disease high blood pressure thyroid disease diabetes persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus)"],"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 do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor Age Dose children 6 years to under 12 years 10 mL every 4 hours children 4 years to under 6 years 5 mL every 4 hours children under 4 years do not use mL=milliliter"],"dosage_and_administration_table":["
Age Dose
children 6 years to under 12 years10 mL every 4 hours
children 4 years to under 6 years5 mL every 4 hours
children under 4 yearsdo not use
"],"effective_time":"20241216","id":"8e10d570-5e78-4ff3-9a30-bbdba6912b74","inactive_ingredient":["INACTIVE INGREDIENTS citric acid anhydrous, D&C red #33, dextrose, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum"],"indications_and_usage":["USES helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep nasal congestion due to a cold stuffy nose"],"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 (1-800-222-1222) right away."],"openfda":{"application_number":["M012"],"brand_name":["Leader Childrens Multi Symptom Cold"],"generic_name":["DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["CARDINAL HEALTH 110, LLC. DBA LEADER"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["70000-0629-1"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["70000-0629"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1043543"],"spl_id":["8e10d570-5e78-4ff3-9a30-bbdba6912b74"],"spl_set_id":["169ff9cf-fcf5-46a6-b460-259421f2ec07"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"other_safety_information":["OTHER INFORMATION each 5 mL contains: potassium 5 mg, sodium 5 mg store between 15-30 ºC (59-86 ºF) do not refrigerate dosing cup provided"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL LEADER NDC 70000-0629-1 Children's Multi-Symptom Cold Dextromethorphan HBr Guaifenesin Phenylephrine HCl Cough Suppressant Expectorant Nasal Decongestant Very Berry Flavor Ages 4+ Years Relieves: Stuffy Nose Chest Congestion Controls Cough Breaks Up Mucus COMPARE TO CHILDREN'S MUCINEX ® MULTI-SYMPTOM COLD active ingredients* 4FL OZ (118 mL) LDR_615_Carton 615_LDR_Labl"],"purpose":["PURPOSE Cough suppressant Expectorant Nasal decongestant"],"questions":["QUESTIONS OR COMMENTS? call (609) 860-2600 Mon - Fri 8:00 am to 4:30 pm est"],"set_id":"169ff9cf-fcf5-46a6-b460-259421f2ec07","spl_product_data_elements":["Leader Childrens Multi Symptom Cold Dextromethorphan HBr, guaifenesin, Phenylephrine HCl DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID D&C RED NO. 33 DEXTROSE EDETATE DISODIUM GLYCERIN METHYLPARABEN FD&C BLUE NO. 1 FD&C RED NO. 40 POTASSIUM SORBATE PROPYL GALLATE PROPYLENE GLYCOL PROPYLPARABEN WATER SACCHARIN SODIUM ANHYDROUS SODIUM HYDROXIDE SORBITOL SUCRALOSE XANTHAN GUM"],"stop_use":["STOP USE AND ASK DOCTOR IF your child gets nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness."],"version":"3","warnings":["WARNINGS ."],"when_using":["WHEN USING THIS PRODUCT do not use more than directed"]}