{ "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": "2026-06-09", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "spl_product_data_elements": [ "Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE Acetaminophen, Chlorpheniramine Maleate, and Dextromethorphan Hydrobromide FD&C BLUE NO. 1 ANHYDROUS CITRIC ACID FD&C RED NO. 40 MICROCRYSTALLINE CELLULOSE GLYCERIN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM WATER SODIUM BENZOATE SORBITOL SOLUTION SUCROSE ACETAMINOPHEN ACETAMINOPHEN XANTHAN GUM CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN D&C RED NO. 33" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredients (in each 5 mL) Purposes Acetaminophen 160 mg Pain reliever/fever reducer Chlorpheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 5 mg Cough suppressant" ], "active_ingredient_table": [ "
Active ingredients (in each 5 mL)Purposes
Acetaminophen 160 mgPain reliever/fever reducer
Chlorpheniramine maleate 1 mgAntihistamine
Dextromethorphan HBr 5 mgCough suppressant
" ], "purpose": [ "Active ingredients (in each 5 mL) Purposes Acetaminophen 160 mg Pain reliever/fever reducer Chlorpheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 5 mg Cough suppressant" ], "purpose_table": [ "
Active ingredients (in each 5 mL)Purposes
Acetaminophen 160 mgPain reliever/fever reducer
Chlorpheniramine maleate 1 mgAntihistamine
Dextromethorphan HBr 5 mgCough suppressant
" ], "indications_and_usage": [ "Uses temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat sneezing and runny nose cough temporarily reduces fever" ], "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. to make a child sleepy 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 a breathing problem such as chronic bronchitis glaucoma 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 taking sedatives or tranquilizers When using this product do not exceed recommended dose (see overdose warning ) marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children 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." ], "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. to make a child sleepy 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_doctor": [ "Ask a doctor before use if your child has liver disease a breathing problem such as chronic bronchitis glaucoma 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 taking sedatives or tranquilizers" ], "when_using": [ "When using this product do not exceed recommended dose (see overdose warning ) marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children" ], "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." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "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 do not use unless directed by a doctor 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 yearsdo not use unless directed by a doctor
48-956 to 11 years10 mL
" ], "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" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum" ], "questions": [ "Questions or comments? call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-245-01 Children's TYLENOL ® COLD + COUGH + RUNNY NOSE Acetaminophen, Pain Reliever-Fever Reducer Dextromethorphan HBr, Cough Suppressant Chlorpheniramine Maleate, Antihistamine Oral Suspension Ages 6-11 Years FEVER SORE THROAT SNEEZING RUNNY NOSE COUGH 4 fl oz (120 mL) Grape Flavor Principal Display Panel" ], "set_id": "5b95905e-b729-4caf-921a-fc4ef815289c", "id": "2e68d5d9-e9e2-7e7d-e063-6294a90aa3a1", "effective_time": "20250218", "version": "9", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE" ], "generic_name": [ "ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE" ], "manufacturer_name": [ "Kenvue Brands LLC" ], "product_ndc": [ "50580-245" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "CHLORPHENIRAMINE MALEATE", "DEXTROMETHORPHAN HYDROBROMIDE" ], "rxcui": [ "1086750" ], "spl_id": [ "2e68d5d9-e9e2-7e7d-e063-6294a90aa3a1" ], "spl_set_id": [ "5b95905e-b729-4caf-921a-fc4ef815289c" ], "package_ndc": [ "50580-245-01", "50580-245-02", "50580-245-12" ], "is_original_packager": [ true ], "upc": [ "0300450161048" ], "unii": [ "362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH" ] } } ] }