"],"ask_doctor":["Ask a doctor before use if the child has ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ 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 ▪ do not give 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 of age 10 mL every 4 hours children 4 to under 6 years of age 5 mL every 4 hours children under 4 years of age do not use"],"dosage_and_administration_table":["
Age
Dose
children 6 years to under 12 years of age
10 mL every 4 hours
children 4 to under 6 years of age
5 mL every 4 hours
children under 4 years of age
do not use
"],"effective_time":"20260807","id":"531a4343-0b95-456f-90cd-2c55769c3ae3","inactive_ingredient":["Inactive ingredients anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, potassium citrate, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum"],"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 ▪ temporarily relieves: ▪ cough due to minor throat and bronchial irritation as may occur with the common 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 right away at 1-800-222-1222."],"openfda":{"application_number":["M012"],"brand_name":["Winco Foods Childrens Multi Symptom Cold"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["WINCO FOODS, LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["67091-355-18"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["67091-355"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["531a4343-0b95-456f-90cd-2c55769c3ae3"],"spl_set_id":["1d02b32a-e88d-4c70-b66d-7bdc22c25a43"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton NDC 67091-355-18 Children's Multi-Symptom Cold Dextromethorphan HBr-Cough Suppressant Guaifenesin- Expectorant Phenylephrine HCl - Nasal Decongestant • Relieves Stuffy Nose • Controls Cough • Relieves Chest Congestion • Breaks up Mucus Dosing Cup Included For Ages 4 & Over Berry Flavor Naturally and Artificially Flavored 4 FL OZ (118 mL) IMPORTANT: Keep this carton for future reference on full labeling. TAMPER-EVEDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING. Distributed by: *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex® Multi-Symptom Cold. Winco Foods Children's Multi Symptom Cold Relief Berry Flavor"],"package_label_principal_display_panel_table":["
IMPORTANT: Keep this carton for future reference on full labeling.
","
TAMPER-EVEDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING.
"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"1d02b32a-e88d-4c70-b66d-7bdc22c25a43","spl_product_data_elements":["Winco Foods Childrens Multi Symptom Cold Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride Dextromethorphan Hydrobromide Dextromethorphan Guaifenesin Guaifenesin Phenylephrine Hydrochloride Phenylephrine ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C RED NO. 40 POTASSIUM CITRATE PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • 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 condition."],"storage_and_handling":["Other information • each 5 mL contains: sodium 2 mg • store at room temperature • do not refrigerate • use dosing cup provided"],"version":"7","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 ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ cough that occurs with too much phlegm (mucus) ▪ persistent or chronic cough such as occurs with asthma When using this product do not use more than directed Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • 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 condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222."],"when_using":["When using this product do not use more than directed"]}