{
"meta": {
"disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
"terms": "https://open.fda.gov/terms/",
"license": "https://open.fda.gov/license/",
"last_updated": "2026-10-02",
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{
"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"
],
"active_ingredient": [
"Drug Facts Active ingredients (in each 5 mL) Guaifenesin, USP 100 mg Phenylephrine HCl, 2.5 mg"
],
"purpose": [
"Purposes Expectorant Nasal Decongestant"
],
"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"
],
"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_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"
],
"when_using": [
"When using this product Do not use more than directed"
],
"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."
],
"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)."
],
"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": [
"
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
"
],
"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"
],
"inactive_ingredient": [
"Inactive ingredients anhydrous citric acid, edetate disodium, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum."
],
"questions": [
"Questions or Comments? 1-866-467-2748"
],
"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": [
"
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.