{"active_ingredient":["Active ingredients (in each 5 mL) Purposes Acetaminophen 160 mg Pain reliever/fever reducer Dextromethorphan HBr 5 mg Cough suppressant"],"active_ingredient_table":["
Active ingredients (in each 5 mL)Purposes
Acetaminophen 160 mgPain reliever/fever reducer
Dextromethorphan HBr 5 mgCough suppressant
"],"ask_doctor":["Ask a doctor before use if your child has liver disease persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus)"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin"],"do_not_use":["Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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. if your child has ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning ) shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age. remove the child protective cap and squeeze your child's dose into the dosing cup repeat dose every 4 hours, while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) under 36 under 4 years do not use 36-47 4 to 5 years 5 mL 48-95 6 to 11 years 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device."],"dosage_and_administration_table":["
Weight (lb)Age (yr)Dose (mL)
under 36under 4 yearsdo not use
36-474 to 5 years5 mL
48-956 to 11 years10 mL
"],"effective_time":"20241107","id":"21d4a287-1f3b-ce36-e063-6294a90a1ef3","inactive_ingredient":["Inactive ingredients anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum"],"indications_and_usage":["Uses temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat cough temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT"],"generic_name":["ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE"],"is_original_packager":[true],"manufacturer_name":["Kenvue Brands LLC"],"package_ndc":["50580-194-01"],"product_ndc":["50580-194"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1370113"],"spl_id":["21d4a287-1f3b-ce36-e063-6294a90a1ef3"],"spl_set_id":["e83f7911-22b4-4ffc-8f49-68f6acd2ebf5"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["362O9ITL9D","9D2RTI9KYH"],"upc":["0300450169044"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 50580-194-01 Children's TYLENOL ® COLD + COUGH + SORE THROAT Acetaminophen, Pain Reliever-Fever Reducer Dextromethorphan HBr, Cough Suppressant Oral Suspension Ages 4-11 Years FEVER SORE THROAT COUGH 4 fl oz (120 mL) Bubblegum Flavor Principal Display Panel"],"purpose":["Active ingredients (in each 5 mL) Purposes Acetaminophen 160 mg Pain reliever/fever reducer Dextromethorphan HBr 5 mg Cough suppressant"],"purpose_table":["
Active ingredients (in each 5 mL)Purposes
Acetaminophen 160 mgPain reliever/fever reducer
Dextromethorphan HBr 5 mgCough suppressant
"],"questions":["Questions or comments? call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)"],"set_id":"e83f7911-22b4-4ffc-8f49-68f6acd2ebf5","spl_product_data_elements":["Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT Acetaminophen and Dextromethorphan Hydrobromide ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN MICROCRYSTALLINE CELLULOSE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM WATER SODIUM BENZOATE SORBITOL SOLUTION SUCROSE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition."],"storage_and_handling":["Other information store between 20-25°C (68-77°F) do not use if carton is opened or if carton tape or bottle wrap imprinted \"TYLENOL\" is broken or missing"],"version":"6","warnings":["Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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 with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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. if your child has ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if your child has liver disease persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin When using this product do not exceed recommended dose (see overdose warning ) Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"when_using":["When using this product do not exceed recommended dose (see overdose warning )"]}