{"active_ingredient":["Active ingredients (in each 5 mL) Purpose Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant"],"active_ingredient_table":["
Active ingredients (in each 5 mL)Purpose
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant
"],"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"],"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 5 mL – 10 mL every 4 hours children 4 years to under 6 years of age 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 years of age5 mL – 10 mL every 4 hours
children 4 years to under 6 years of age2.5 mL – 5 mL every 4 hours
children under 4 yearsdo not use
"],"effective_time":"20251111","id":"434f6496-b36a-c575-e063-6294a90ac9ba","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"],"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"],"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":["TOPCO Childrens Cough Relief"],"generic_name":["DEXTROMETHORPHAN HBR AND GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Topco Associates, LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["76162-751-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["76162-751"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020138"],"spl_id":["434f6496-b36a-c575-e063-6294a90ac9ba"],"spl_set_id":["ee0f5627-5104-4990-88ee-2fb46965bc1e"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton Compare to the Active Ingredients in Children’s Mucinex ® cough* NDC 76162-751-04 Children's Cough Relief Dextromethorphan HBr 5 mg Guaifenesin 100 mg Controls Cough Relieves Chest Congestion Breaks up Mucus Ages 4 + years Natural Cherry F lavor 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. Distributed by: TOPCO Children's Cough Relief 4 FL OZ Cherry Flavor"],"package_label_principal_display_panel_table":["
IMPORTANT: Keep this carton for future reference on full labeling.
"],"purpose":["Active ingredients (in each 5 mL) Purpose Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant"],"purpose_table":["
Active ingredients (in each 5 mL)Purpose
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant
"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"ee0f5627-5104-4990-88ee-2fb46965bc1e","spl_product_data_elements":["TOPCO Childrens Cough Relief DEXTROMETHORPHAN HBr AND GUAIFENESIN ANHYDROUS CITRIC ACID EDETATE SODIUM 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","TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP ID TORN OR MISSING"],"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."],"storage_and_handling":["Other information each 5 mL contains : sodium 2 mg store at room temperature do not refrigerate"],"version":"2","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 When Using this product do not use more than directed 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."],"when_using":["When Using this product do not use more than directed"]}