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"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 Cough Relief DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID EDETATE SODIUM FD&C RED NO. 40 POTASSIUM CITRATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM"
],
"spl_unclassified_section": [
"Drug Facts",
""
],
"active_ingredient": [
"Active ingredients (in each 5 mL) Purpose Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant"
],
"active_ingredient_table": [
"
"
],
"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"
],
"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 • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with asthma Stop use and ask a doctor if 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."
],
"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."
],
"ask_doctor": [
"Ask a doctor before use if the child has • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with asthma"
],
"stop_use": [
"Stop use and ask a doctor if 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": [
"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."
],
"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 5 mL – 10 mL every 4 hours children 4 years to under 6 years 2.5 mL – 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
5 mL – 10 mL every 4 hours
children 4 years to under 6 years
2.5 mL – 5 mL every 4 hours
children under 4 years
do not use
"
],
"storage_and_handling": [
"Other information • each 5 mL contains : sodium 2 mg • Tamper evident: do not use if printed inner seal under cap is torn or missing • store at room temperature • do not refrigerate"
],
"inactive_ingredient": [
"Inactive ingredients anhydrous citric acid, edetate disodium, FD&C red #40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum"
],
"questions": [
"Questions or comments? 1-866-467-2748"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton Compare to the Active Ingredients in Children’s Mucinex ® cough NDC 69842-577-04 Children's Cough Relief Dextromethorphan HBr , 5 mg Guaifenesin,100 mg Natural Cherry F lavor Dosage Cup Included Ages 4 + years Controls Cough Relieves Chest Congestion Breaks up Mucus 4 FL OZ (118 mL) *This product is not manufactured or distributed by RB Health (USA), distributor of Children’s Mucinex ® Cough. IMPORTANT: Keep this carton for future reference on full labeling. Children's Mucus and Cough Relief 4 FL OZ Cherry Flavor"
],
"package_label_principal_display_panel_table": [
"
IMPORTANT: Keep this carton for future reference on full labeling.