{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 18 } }, "results": [ { "spl_product_data_elements": [ "Childrens Mucus and Cough Relief GUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C RED NO. 40 POTASSIUM CITRATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant" ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant
" ], "purpose": [ "Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant" ], "purpose_table": [ "
Active ingredients (in each 5 mL)Purposes
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant
" ], "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 illness. 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 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 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 mL = milliliter 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": [ "
AgeDose
children 6 years to under 12 years5 mL – 10 mL every 4 hours
children 4 years to under 6 years2.5 mL – 5 mL every 4 hours
children under 4 yearsdo not use
" ], "storage_and_handling": [ "Other information each 5 mL contains: sodium 3 mg Tamper -evident: do not use if printed inner seal under cap is torn or missing store at room temperature do not refrigerate dosing cup provided" ], "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" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton NDC 63868-771-04 Compare to the Active ingredient in Children’s Mucinex Cough* Children's Mucus &Cough Relief Cough Suppressant Expectorant Dextromethorphan HBr Guaifenesin Each Dose of Cherry Flavored Children's Mucus & Cough Relief: Controls Cough Relieves Chest Congestion Breaks up Mucus Alcohol-free See New Dosing information Cherry Flavor 4 FL OZ (118 mL) IMPORTANT: Keep this carton for future reference on full labeling. DOSAGE CUP INCLUDED Distributed by C.D.M.A., Inc© 43157 W. Nine Mile Novi, MI 48376-0995 www.qualitychoice.com Questions: 248-449-9300 *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex.® QC 100% Satisfaction Guaranteed. Quality Choice Children's Mucus and Cough Relief Cherry Flavor 4 FL OZ" ], "package_label_principal_display_panel_table": [ "
IMPORTANT: Keep this carton for future reference on full labeling.
" ], "set_id": "06822a28-3f82-471d-8db5-c5981b263a03", "id": "451db5bd-8360-738c-e063-6294a90a1d60", "effective_time": "20251204", "version": "8", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Childrens Mucus and Cough Relief" ], "generic_name": [ "GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE" ], "manufacturer_name": [ "Chain Drug Manufacturing Assn" ], "product_ndc": [ "63868-771" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DEXTROMETHORPHAN HYDROBROMIDE", "GUAIFENESIN" ], "rxcui": [ "1020138" ], "spl_id": [ "451db5bd-8360-738c-e063-6294a90a1d60" ], "spl_set_id": [ "06822a28-3f82-471d-8db5-c5981b263a03" ], "package_ndc": [ "63868-771-04" ], "is_original_packager": [ true ], "nui": [ "N0000193956", "N0000008867", "N0000009560" ], "pharm_class_epc": [ "Expectorant [EPC]" ], "pharm_class_pe": [ "Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]" ], "unii": [ "9D2RTI9KYH", "495W7451VQ" ] } } ] }