{ "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 FORMULA 44DM NIGHTTIME COUGH and COLD Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate XANTHAN GUM SUCRALOSE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN SORBITOL PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN" ], "spl_unclassified_section": [ "Drug Facts", "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.", "DIST. BY PROCTER & GAMBLE, CINCINNATI OH 45202" ], "active_ingredient": [ "Active ingredients (in each 30 mL) Acetaminophen 650 mg Chlorpheniramine maleate 4 mg Dextromethorphan HBr 30 mg Purpose Pain reliever/Fever reducer Antihistamine Cough suppressant" ], "purpose": [ "Purpose Pain reliever/Fever reducer Antihistamine Cough suppressant" ], "indications_and_usage": [ "Uses temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing" ], "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 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 is 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_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 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 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 , 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 6 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 & over30 mL every 6 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
" ], "storage_and_handling": [ "Other information each 30 mL dose cup contains: sodium 25 mg store at no greater than 25°C and do not refrigerate" ], "inactive_ingredient": [ "Inactive ingredients citric acid, FD&C Red No. 40, 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 ® FORMULA 44™DM Nighttime COUGH & COLD Acetaminophen Dextromethorphan HBr, Chlorpheniramine Maleate Fever, Minor Aches & Pains Cough Sneezing, Runny Nose 12 FL OZ (354 mL) 450" ], "set_id": "05414779-f61d-8fa7-e063-6394a90aa034", "id": "4040f61e-bc9e-6060-e063-6294a90a7b96", "effective_time": "20251003", "version": "5", "openfda": { "application_number": [ "M012" ], "brand_name": [ "VICKS FORMULA 44DM NIGHTTIME COUGH and COLD" ], "generic_name": [ "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE" ], "manufacturer_name": [ "Procter & Gamble Manufacturing Company" ], "product_ndc": [ "69423-811" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "CHLORPHENIRAMINE MALEATE", "DEXTROMETHORPHAN HYDROBROMIDE" ], "rxcui": [ "1292342" ], "spl_id": [ "4040f61e-bc9e-6060-e063-6294a90a7b96" ], "spl_set_id": [ "05414779-f61d-8fa7-e063-6394a90aa034" ], "package_ndc": [ "69423-811-12" ], "is_original_packager": [ true ], "upc": [ "0323900039193" ], "unii": [ "362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH" ] } } ] }