{"active_ingredient":["Drug Facts Active ingredients (in each 5 mL) Guaifenesin, USP 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 ▪ cough that occurs with too much phlegm (mucus) ▪ persistent or chronic cough such as occurs with asthma"],"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 ▪ mL= milliliter 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"],"dosage_and_administration_table":["<table cellpadding=\"0pt\" cellspacing=\"0pt\" width=\"100%\"><col width=\"49%\"/><col width=\"49%\"/><tbody><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Age</content> </paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Dose</content> </paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Children 6 years to under 12 years </paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>10 mL every 4 hours  </paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>Children 4 years to under 6 years </paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>5 mL every 4 hours</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>Children under 4 years </paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">do not use</content> </paragraph></td></tr></tbody></table>"],"effective_time":"20260819","id":"e5050d2d-a616-477d-83ac-c628b888a275","inactive_ingredient":["Inactive ingredients anhydrous citric acid, edetate disodium, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, 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: ▪ 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 (1-800-222-1222)."],"openfda":{"application_number":["M012"],"brand_name":["CVS"],"generic_name":["CHILDRENS STUFFY NOSE AND COLD"],"is_original_packager":[true],"manufacturer_name":["CVS PHARMACY, INC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["69842-487-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["69842-487"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1485599"],"spl_id":["e5050d2d-a616-477d-83ac-c628b888a275"],"spl_set_id":["6cff265d-94a3-4617-a366-fe970d97f05a"],"substance_name":["GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["Package Label-Principal Display Panel 4 FL OZ (118 mL Bottle) Compare to the Active Ingredients in Children’s Mucinex® Stuffy Nose & Cold NDC 69842-487-04 Children's Stuffy Nose & Cold Relief Guaifenesin Expectorant Phenylephrine Hcl Nasal Decongestant • Stuffy Nose • Chest Congestion • Breaks Up Mucus Dosage Cup Included For Ages 4 & Over Dye Free Mixed Berry Flavor Naturally and Artificially Flavored 4 FL OZ (118 mL) TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING IMPORTANT: Keep this carton for future reference on full labeling. Distributed by: CVS Children's Stuffy Nose and Cold Relief Syrup"],"package_label_principal_display_panel_table":["<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"100%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING</paragraph></td></tr></tbody></table>","<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"100%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>IMPORTANT: Keep this carton for future reference on full labeling.</paragraph></td></tr></tbody></table>"],"purpose":["Purposes Expectorant Nasal Decongestant"],"questions":["Questions or Comments? 1-866-467-2748"],"set_id":"6cff265d-94a3-4617-a366-fe970d97f05a","spl_product_data_elements":["CVS Childrens Stuffy Nose and Cold GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM"],"stop_use":["Stop use and ask a 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."],"storage_and_handling":["Other information ▪ each 5 mL contains : sodium 3 mg ▪ very low sodium ▪ store at room temperature ▪ do not refrigerate ▪ dosing cup provided"],"version":"6","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."],"when_using":["When using this product Do not use more than directed"]}