{ "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": 7 } }, "results": [ { "spl_product_data_elements": [ "Daytime and Nighttime Cherry Cold and Flu Daytime - Acetaminophen, Dextromethrophan HBr Nighttime - Acetaminophen, Dextromethrophan HBr, Doxylamine succinate Daytime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE SORBITOL SUCRALOSE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN Nighttime Cherry Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate ALCOHOL CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE" ], "spl_unclassified_section": [ "NyQuil Cold & Flu Drug Facts", "Dist. by Procter & Gamble, Cincinnati OH 45202", "DayQuil Cold & Flu Drug Facts", "Tamper Evident: Do not use if printed shrinkband seal around the neck is broken or missing.", "Dist. by Procter & Gamble, Cincinnati OH 45202" ], "active_ingredient": [ "Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg Purpose Pain reliever/ fever reducer Cough suppressant Antihistamine", "Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg Purpose Pain reliever/Fever reducer Cough suppressant Nasal decongestant" ], "purpose": [ "Purpose Pain reliever/ fever reducer Cough suppressant Antihistamine", "Purpose Pain reliever/Fever reducer Cough suppressant Nasal decongestant" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose and sneezing", "Uses temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses 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 avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if pain 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.", "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adults take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product child take more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product 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 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 heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if You get nervous, dizzy, or sleepless. Pain, nasal congestion or cough get worse or last more than 5 days (children) or 7 days (adults) Fever gets worse or last 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.", "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 a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium-restricted diet" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin", "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "when_using": [ "When using this product 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", "When using this product, do not use more than directed." ], "stop_use": [ "Stop use and ask a doctor if pain 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.", "Stop use and ask a doctor if You get nervous, dizzy, or sleepless. Pain, nasal congestion or cough get worse or last more than 5 days (children) or 7 days (adults) Fever gets worse or last 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.", "If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "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.", "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 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use", "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 ask a doctor children under 4 yrs do not use" ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over30 mL every 6 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
", "
adults & children 12 yrs & over30 mL every 4 hrs
children 6 to under 12 yrs15 mL every 4 hrs
children 4 to under 6 yrsask a doctor
children under 4 yrsdo not use
" ], "storage_and_handling": [ "Other information each 30 mL tablespoon contains: sodium 24 mg store at no greater than 25°C and do not refrigerate", "Other information each 15 mL contains : sodium 46 mg store at no greater than 25°C and do not refrigerate." ], "inactive_ingredient": [ "Inactive ingredients alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum", "Inactive ingredients citric acid, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum" ], "questions": [ "Questions? 1-800-362-1683", "Questions? 1-800-362-1683" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - Convenience Pack POWERFUL RELIEF Day & Night Pack VICKS ® DayQuil ™ COLD & FLU Multi-Symptom Relief Acetaminophen , Phenylephrine HCl, Dextromethorphan HBr Headache, Fever, Sore Throat, Minor Aches & Pains Nasal Congestion, Sinus Pressure Cough Non-Drowsy Alcohol Free NyQuil ™ COLD & FLU Nighttime Relief Acetaminophen , Doxylamine Succinate, Dextromethorphan HBr Headache, Fever, Sore Throat Minor Aches & Pains Sneezing, Runny Nose Cough Nighttime Relief Alcohol 10% TWO 12 FL OZ (354 ml) BOTTLES TOTAL 24 FL OZ (708 ml) 031" ], "set_id": "0903b222-1a44-64aa-e063-6294a90abba0", "id": "0903ad7d-a62e-5ea0-e063-6294a90a4a83", "effective_time": "20231031", "version": "1", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Daytime and Nighttime Cherry Cold and Flu" ], "generic_name": [ "DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE" ], "manufacturer_name": [ "TARGET CORPORATION" ], "product_ndc": [ "11673-921" ], "product_type": [ "HUMAN OTC DRUG" ], "rxcui": [ "1043400", "1113705", "2604561", "2637726" ], "spl_id": [ "0903ad7d-a62e-5ea0-e063-6294a90a4a83" ], "spl_set_id": [ "0903b222-1a44-64aa-e063-6294a90abba0" ], "package_ndc": [ "11673-921-02" ], "is_original_packager": [ true ] } } ] }