{ "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": 1 } }, "results": [ { "spl_product_data_elements": [ "DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSX acetaminophen, dextromethorphan hydrobromide tablet, coated MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED FD&C YELLOW NO. 6 ALUMINUM LAKE POVIDONE, UNSPECIFIED STEARIC ACID SUCRALOSE TITANIUM DIOXIDE STARCH, CORN CROSPOVIDONE SILICON DIOXIDE TALC MAGNESIUM STEARATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN DQV DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), Lil Drug Store acetaminophen, dextromethorphan hydrobromide tablet, coated MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED MAGNESIUM STEARATE FD&C YELLOW NO. 6 ALUMINUM LAKE POVIDONE, UNSPECIFIED STEARIC ACID SUCRALOSE TITANIUM DIOXIDE STARCH, CORN CROSPOVIDONE SILICON DIOXIDE TALC DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN DQV DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), CVP acetaminophen, dextromethorphan hydrobromide tablet, coated MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED FD&C YELLOW NO. 6 ALUMINUM LAKE POVIDONE, UNSPECIFIED STEARIC ACID SUCRALOSE TITANIUM DIOXIDE STARCH, CORN CROSPOVIDONE SILICON DIOXIDE TALC MAGNESIUM STEARATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN DQV" ], "spl_unclassified_section": [ "Drug Facts", "Other information Other information store at no greater than 25°C (77°F)" ], "active_ingredient": [ "Active ingredients (in each caplet) Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Purpose ​Purpose Pain reliever/fever reducer Cough suppressant" ], "purpose": [ "Purpose ​Purpose Pain reliever/fever reducer Cough suppressant" ], "indications_and_usage": [ "Uses Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever" ], "warnings": [ "Warnings Warnings Liver warning ​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 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 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 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 Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if 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 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." ], "do_not_use": [ "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 Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin." ], "stop_use": [ "Stop use and ask a doctor if 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." ], "pregnancy_or_breast_feeding": [ "If pregnant 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 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." ], "dosage_and_administration": [ "Directions 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
" ], "inactive_ingredient": [ "Inactive ingredients Inactive ingredients corn starch, crospovidone, FD&C Yellow No. 6 Aluminum Lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide" ], "questions": [ "Questions? Questions? 1-800-362-1683" ], "package_label_principal_display_panel": [ "DayQuil ™ Cold & Flu w/VapoCOOL, 4ct (PE-free), Lil' Drug Store ® VICKS DayQuil ™ COLD & FLU Acetaminophen, Dextromethorphan HBr [caplet image] Headache, Fever, Sore Throat, Minor Aches & Pains Cough Vapo Cool COATED 4 Coated Caplets [Lil' Drug Store ® logo] PDP/Package", "DayQuil ™ Cold & Flu w/VapoCOOL, 4ct (PE-free), CVP ® HEALTH VICKS DayQuilTM COLD & FLU Acetaminophen, Dextromethorphan HBr [caplet image] Headache, Fever, Sore Throat, Minor Aches & Pains Cough Vapo Cool COATED 4 Coated Caplets [CVP ® HEALTH logo] PDP/Package", "DayQuil ™ Cold & Flu w/VapoCOOL, 4ct (PE-free), Travel BASIX VICKS DayQuil ™ COLD & FLU Acetaminophen, Dextromethorphan HBr [caplet image] Headache, Fever, Sore Throat, Minor Aches & Pains Cough Vapo Cool COATED 4 Coated Caplets [Travel BASIX logo] PDP/Package" ], "set_id": "37c55543-e05e-2f7c-e063-6394a90a4534", "id": "3803c442-acc5-06e7-e063-6294a90ac5a7", "effective_time": "20250620", "version": "2", "openfda": { "application_number": [ "M012" ], "brand_name": [ "DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSX", "DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), CVP", "DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), Lil Drug Store" ], "generic_name": [ "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATED" ], "manufacturer_name": [ "Lil' Drug Store Products, Inc." ], "product_ndc": [ "66715-6204", "66715-9604", "66715-6804" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXTROMETHORPHAN HYDROBROMIDE" ], "rxcui": [ "2709673" ], "spl_id": [ "3803c442-acc5-06e7-e063-6294a90ac5a7" ], "spl_set_id": [ "37c55543-e05e-2f7c-e063-6394a90a4534" ], "package_ndc": [ "66715-6204-2", "66715-9604-2", "66715-6804-2" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "9D2RTI9KYH" ] } } ] }