{ "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": 93 } }, "results": [ { "spl_product_data_elements": [ "Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM clear, dark" ], "active_ingredient": [ "Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg" ], "purpose": [ "Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: • sinus congestion and pressure • nasal congestion • minor aches and pains • headache • runny nose and sneezing • sore throat • cough to help you sleep • fever • cough due to minor throat and bronchial irritation • reduces swelling of nasal passages • promotes nasal and/or sinus drainage • temporarily restores freer breathing through the nose" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • 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. • if you have ever had an allergic reaction to this product or any of its ingredients 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 such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • 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 sedatives or tranquilizers • taking the blood thinning drug warfarin 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 and ask a doctor if • you get nervous, dizzy or sleepless • 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. 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. • 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. • if you have ever had an allergic reaction to this product or any of its ingredients" ], "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 such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • 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" ], "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 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. 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." ], "dosage_and_administration": [ "Directions • take only as directed – see Overdose warning • 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 4 to under 12 yrs ask a doctor children under 4 yrs do not use Other information • each 30 mL contains: sodium 41 mg • store at 20-25°C (68-77°F)" ], "dosage_and_administration_table": [ "
adults & children 12 yrs & over30 mL every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
" ], "storage_and_handling": [ "Other information • each 30 mL contains: sodium 41 mg • store at 20-25°C (68-77°F)" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum Questions? 1-800-719-9260" ], "questions": [ "Questions? 1-800-719-9260" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Walgreens WALGREENS PHARMACIST RECOMMENDED Compare to the active ingredients in Vicks ® NyQuil ® Severe Cold & Flu NIGHTTIME Severe Cold & Flu ACETAMINOPHEN / ACHES / FEVER / SORE THROAT DEXTROMETHORPHAN HBr / COUGH DOXYLAMINE SUCCINATE / SNEEZING / RUNNY NOSE PHENYLEPHRINE HCl / NASAL & SINUS CONGESTION / SINUS PRESSURE Maximum Strength • Pain reliever, fever reducer, cough suppressant, antihistamine & nasal decongestant • Alcohol free Mixed Berry flavor 12 FL OZ (355 mL) nighttime severe cold and flu image" ], "set_id": "02f3e739-3153-412f-b2cd-6f01dcd5875b", "id": "f1c880ee-6551-4a24-a3d2-8a518e4b1b1c", "effective_time": "20241030", "version": "8", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Severe Cold and Flu" ], "generic_name": [ "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL" ], "manufacturer_name": [ "Walgreen Company" ], "product_ndc": [ "0363-0763" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXTROMETHORPHAN HYDROBROMIDE", "DOXYLAMINE SUCCINATE", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1431245" ], "spl_id": [ "f1c880ee-6551-4a24-a3d2-8a518e4b1b1c" ], "spl_set_id": [ "02f3e739-3153-412f-b2cd-6f01dcd5875b" ], "package_ndc": [ "0363-0763-40" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ" ] } } ] }