{ "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": "2026-06-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "Vicks NyQuil VapoCOOL COLD and FLU Acetaminophen, Doxylamine Succinate, Dextromethorphan Hydrobromide SILICON DIOXIDE CROSPOVIDONE D&C YELLOW NO. 10 ALUMINUM LAKE MAGNESIUM STEARATE POLYETHYLENE GLYCOL FD&C BLUE NO. 2 ALUMINUM LAKE MICROCRYSTALLINE CELLULOSE STARCH, CORN FD&C YELLOW NO. 6 ALUMINUM LAKE POLYVINYL ALCOHOL POVIDONE STEARIC ACID TALC TITANIUM DIOXIDE SUCRALOSE ACETAMINOPHEN ACETAMINOPHEN DOXYLAMINE SUCCINATE DOXYLAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN NQV" ], "spl_unclassified_section": [ "Drug Facts", "TAMPER EVIDENT: THIS PACKAGE IS SAFETY-SEALED & CHILD RESISTANT. USE ONLY IF BLISTERS ARE INTACT. IF DIFFICULT TO OPEN, USE SCISSORS.", "DIST. BY PROCTER & GAMBLE, CINCINNATI OH 45202" ], "active_ingredient": [ "Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Purpose Pain reliever/fever reducer Cough suppressant Antihistamine" ], "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation cough to help you sleep sore throat headache minor aches & pains fever runny nose & sneezing" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 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 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 you are 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 liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain, nasal congestion, or cough gets worse or lasts more than 7 days 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 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. if you are 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_doctor": [ "Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin" ], "when_using": [ "When using this product excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "stop_use": [ "Stop use and ask a doctor if pain, nasal congestion, or cough gets worse or lasts more than 7 days 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." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "overdosage": [ "In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "dosage_and_administration": [ "Directions take only as directed do not exceed 8 caplets per 24 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use" ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over2 caplets with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
" ], "storage_and_handling": [ "Other information store at no greater than 25ºC (77°F)" ], "inactive_ingredient": [ "Inactive ingredients corn starch, crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow # 6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide" ], "questions": [ "Questions? 1-800-362-1683" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 24 COATED CAPLETS VICKS ® NyQuil™ VapoCOOL™ COLD & FLU Acetaminophen , Doxylamine Succinate, Dextromethorphan HBr •Headache, Fever, Sore Throat, Minor Aches & Pains •Sneezing, Runny Nose •Cough Nighttime Relief 24 COATED CAPLETS 353" ], "set_id": "32819305-9bbd-8843-e063-6294a90a7f2e", "id": "49001eca-3b83-1472-e063-6394a90a5489", "effective_time": "20260122", "version": "6", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Vicks NyQuil VapoCOOL COLD and FLU" ], "generic_name": [ "ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE" ], "manufacturer_name": [ "The Procter & Gamble Manufacturing Company" ], "product_ndc": [ "84126-353" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXTROMETHORPHAN HYDROBROMIDE", "DOXYLAMINE SUCCINATE" ], "rxcui": [ "2713312" ], "spl_id": [ "49001eca-3b83-1472-e063-6394a90a5489" ], "spl_set_id": [ "32819305-9bbd-8843-e063-6294a90a7f2e" ], "package_ndc": [ "84126-353-02", "84126-353-24" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2" ] } } ] }