{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "spl_product_data_elements": [ "VICKS NyQuil SEVERE HONEY FLAVOR COLD and FLU Acetaminophen, Dextromethrophan, Doxylamine succinate, Phenylephrine HCl CITRIC ACID MONOHYDRATE GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE FD&C RED NO. 40 FD&C YELLOW NO. 6 XANTHAN GUM SUCRALOSE SORBITOL FD&C GREEN NO. 3 D&C YELLOW NO. 10 ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE" ], "spl_unclassified_section": [ "Drug Facts", "Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product child takes more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks daily 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.", "In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.", "TAMPER EVIDENT: Do not use if printed shrinkband is broken or missing.", "Made in Canada DIST. BY PROCTER & GAMBLE, CINCINNATI, OH 45202" ], "active_ingredient": [ "Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant" ], "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage" ], "warnings": [ "Warnings" ], "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. to make a child sleepy" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes 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 do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness" ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion or cough gets worse or lasts more than 5 days (children) 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." ], "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." ], "dosage_and_administration": [ "Directions take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs do not use unless directed by a doctor children under 4 yrs do not use" ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over30 mL every 4 hrs
children 6 to under 12 yrs15 mL every 4 hrs
children 4 to under 6 yrsdo not use unless directed by a doctor
children under 4 yrsdo not use
" ], "storage_and_handling": [ "Other information each 15 mL contains: sodium 14 mg Store at no greater than 25º C and do not refrigerate." ], "inactive_ingredient": [ "Inactive ingredients citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum" ], "questions": [ "Questions? 1-800-362-1683" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label VICKS ® NyQuil™ SEVERE HONEY FLAVOR COLD & FLU Acetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr Headache, Fever, Sore Throat, Minor Aches & Pains Nasal Congestion, Sinus Pressure Sneezing, Runny Nose Cough Nighttime Relief 12 FL OZ (354 ml) 807" ], "set_id": "04ca1e9c-f297-cbd6-e063-6294a90a3739", "id": "4040f959-06a0-1b87-e063-6394a90a51ed", "effective_time": "20251003", "version": "6", "openfda": { "application_number": [ "M012" ], "brand_name": [ "VICKS NyQuil SEVERE HONEY FLAVOR COLD and FLU" ], "generic_name": [ "ACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL" ], "manufacturer_name": [ "Procter & Gamble Manufacturing Company" ], "product_ndc": [ "69423-807" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXTROMETHORPHAN HYDROBROMIDE", "DOXYLAMINE SUCCINATE", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1431245" ], "spl_id": [ "4040f959-06a0-1b87-e063-6394a90a51ed" ], "spl_set_id": [ "04ca1e9c-f297-cbd6-e063-6294a90a3739" ], "package_ndc": [ "69423-807-12", "69423-807-08" ], "is_original_packager": [ true ], "upc": [ "0323900041615" ], "unii": [ "362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ" ] } } ] }