{"active_ingredient":["Acetaminophen 162.5 mg Dextromethorphan HBr 5 mg Doxylamine succinate 3.125 mg"],"dosage_and_administration":["Directions ■ do not take more than directed (see Overdose warning) ■ chew thoroughly before swallowing ■ dose every 4 hours or as directed by a doctor adults and children 12 years of age and over 4 chewable tablets every 4 hours, not to exceed 6 doses (24 chewable tablets) in any 24-hour period children 6 to under 12 years of age 2 chewable tablets every 4 hours, not to exceed 5 doses (10 chewable tablets) in any 24-hour period children under 6 years of age do not use"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>adults and children 12 years   of age and over </td><td>4 chewable tablets every 4 hours, not to exceed   6 doses (24 chewable tablets) in any 24-hour period </td></tr><tr><td>children 6 to under 12 years   of age </td><td>2 chewable tablets every 4 hours, not to exceed   5 doses (10 chewable tablets) in any 24-hour period </td></tr><tr><td>children under 6 years of age</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20260513","id":"51bad8ca-7226-ecef-e063-6394a90a8fc3","inactive_ingredient":["Inactive ingredients anhydrous citric acid, corn syrup, ethylcellulose, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, malic acid, maltodextrin, pectin, potassium sodium tartrate, purified water, sodium chloride, sodium polymetaphosphate, sucralose, sucrose, trisodium citrate (anhydrous)"],"indications_and_usage":["Uses ■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ sore throat ■ headache ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ runny nose ■ sneezing ■ temporarily reduces fever ■ controls cough to help the user get to sleep"],"keep_out_of_reach_of_children":["If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Mucinex Childrens Mighty Chews Night Time Cold and Flu"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Reckitt Benckiser LLC"],"package_ndc":["72854-085-16"],"product_ndc":["72854-085"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2715863"],"spl_id":["51bad8ca-7226-ecef-e063-6394a90a8fc3"],"spl_set_id":["2ce31244-9c6c-b7dd-e063-6394a90a31a8"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE","ACETAMINOPHEN"],"unii":["9D2RTI9KYH","V9BI9B5YI2","362O9ITL9D"],"upc":["0363824999623"]},"other_safety_information":["Other information ■ each chewable tablet contains: potassium 5 mg and sodium 13 mg ■ Store in a cool dry place at 20-25°C (68-77°F)"],"package_label_principal_display_panel":["NDC 72854-085-16 Children's Mucinex® Cough Suppressant Antihistamine Acetaminophen 162.5 mg Dextromethorphan HBr 5 mg Doxylamine succinate 3.125 m Age 6+ Mixed Berry Flavor Label"],"purpose":["Acetaminophen 162.5 mg................................................Pain reliever/fever reducer Dextromethorphan HBr 5 mg.......................... ...............Cough suppressant Doxylamine succinate 3.125 mg.................................................Antihistamine"],"questions":["Questions? 1-866-MUCINEX (1-866-682-4639)"],"recent_major_changes":[""],"set_id":"2ce31244-9c6c-b7dd-e063-6394a90a31a8","spl_product_data_elements":["Mucinex Childrens Mighty Chews Night Time Cold and Flu Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN MALIC ACID CORN SYRUP FD&C BLUE NO. 1 SODIUM CHLORIDE ANHYDROUS TRISODIUM CITRATE SUCRALOSE SODIUM POLYMETAPHOSPHATE SUCROSE DOXYLAMINE SUCCINATE DOXYLAMINE ANHYDROUS CITRIC ACID ETHYLCELLULOSE ACETAMINOPHEN ACETAMINOPHEN FD&C RED NO. 40 MALTODEXTRIN PECTIN POTASSIUM SODIUM TARTRATE WATER GLYCERIN Mixed Berry M"],"spl_unclassified_section":["Drug Facts"],"version":"5","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: ■ adult takes more than 6 doses (24 chewable tablets) in 24 hours, which is the maximum daily amount ■ child takes more than 5 doses (10 chewable tablets) in 24 hours, which is the maximum daily amount ■ taken with other drugs containing acetaminophen ■ adult has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use ■ to make a child sleepy ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if the user is now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have ■ has liver disease ■ has a sodium-restricted diet ■ has glaucoma ■ has a breathing problem such as emphysema or chronic bronchitis ■ has difficulty in urination due to enlargement of the prostate gland ■ is a child with pain of arthritis Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers When using this product ■ do not use more than directed (see Overdose warning) ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect ■ avoid alcoholic beverages ■ use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition."]}