{ "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": "2026-06-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "CVS PHARMACY Nighttime MS Flu Relief Acetaminophen, Chlorpheniramine Maleate and Dextromethophan HBr ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ANHYDROUS CITRIC ACID CARAMEL MALTODEXTRIN POTASSIUM CHLORIDE SILICON DIOXIDE SUCRALOSE SUCROSE (white to off-white, yellow, beige, and brown color) Lemon" ], "spl_unclassified_section": [ "Drug Facts", "Other information • each packet contains : potassium 6 mg • store at room temperature. Protect from excessive heat and moisture." ], "active_ingredient": [ "Active ingredients (in each packet) Acetaminophen 1000 mg Chlorpheniramine maleate 4 mg Dextromethorphan HBr 30 mg" ], "purpose": [ "Purposes Pain reliever/Fever reducer Antihistamine Cough suppressant" ], "indications_and_usage": [ "Uses ▪ temporarily relieves these symptoms due to a common cold or flu: ▪ headache ▪ minor aches and pains ▪ cough due to minor throat and bronchial irritation ▪ minor sore throat pain ▪ runny nose ▪ temporarily reduces fever" ], "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 ▪ in a child under 12 years of age ▪ if you are allergic to acetaminophen ▪ 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 a MAO, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have ▪ liver disease ▪ trouble urinating due to an enlarged prostate gland ▪ a breathing problem such as emphysema or chronic bronchitis ▪ cough that occurs with too much phlegm (mucus) ▪ cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are ▪ taking the blood thinning drug warfarin ▪ taking sedatives or tranquilizers When using this product ▪ avoid alcoholic drinks ▪ marked drowsiness may occur ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ be careful when driving a motor vehicle or operating machinery ▪ excitability may occur, especially in children 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 at 1-800-222-1222. Prompt 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 ▪ in a child under 12 years of age ▪ if you are allergic to acetaminophen ▪ 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 a MAO, ask a doctor or pharmacist before taking this product." ], "ask_doctor": [ "Ask a doctor before use if you have ▪ liver disease ▪ trouble urinating due to an enlarged prostate gland ▪ a breathing problem such as emphysema or chronic bronchitis ▪ cough that occurs with too much phlegm (mucus) ▪ cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are ▪ taking the blood thinning drug warfarin ▪ taking sedatives or tranquilizers" ], "when_using": [ "When using this product ▪ avoid alcoholic drinks ▪ marked drowsiness may occur ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ be careful when driving a motor vehicle or operating machinery ▪ excitability may occur, especially in children" ], "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. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt 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 ▪ do not use more than directed ▪ take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use ▪ dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. ▪ if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat" ], "dosage_and_administration_table": [ "AgeDoseadults and children 12 years of age and overone packetchildren under 12 years of agedo not use
" ], "inactive_ingredient": [ "Inactive ingredients anhydrous citric acid, Caramel, flavor, maltodextrin, potassium chloride, silica, sucralose, sucrose" ], "questions": [ "Questions or comments? 1-866-467-2748" ], "package_label_principal_display_panel": [ "Principal Display Panel Compare to the active ingredients in Theraflu Multi-Symptom Flu Relief Max Strength** Nighttime* NDC 51316-945-06 Nighttime Multi-Symptom Flu Relief MAX STRENGTH** Acetaminophen 1000 mg - Pain Reliever/Fever Reducer Chlorpheniramine Maleate 4 mg - Antihistamine Dextromethorphan HBr 30 mg - Cough Suppressant Hot Liquid therapy that relieves: • Fever • Body ache • Headache • Sore throat pain • Cough Honey Lemon Natural & Artificial Flavored 6 PACKAETS **Maximum Strength per 6 hours dose READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD. TAMPER EVIDENT: DO NOT USE INNER SEALED PACKET IF TORN OR BROKEN. *This product is not manufactured or distributed by Haleon group, owner of Theraflu Multi-Symptom Flu Relief Max Strength** Nighttime. Manufactured by: Nighttime MS Flu relief Max strength 6 Packets" ], "set_id": "23cafaa1-34fe-4cef-960b-5f664ea32cb4", "id": "a9d254e3-6157-4a0b-bff6-a07ca3aee7ac", "effective_time": "20260227", "version": "2", "openfda": { "application_number": [ "M012" ], "brand_name": [ "CVS PHARMACY Nighttime MS Flu Relief" ], "generic_name": [ "ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR" ], "manufacturer_name": [ "CVS PHARMACY" ], "product_ndc": [ "51316-945" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "CHLORPHENIRAMINE MALEATE", "DEXTROMETHORPHAN HYDROBROMIDE" ], "rxcui": [ "2636658" ], "spl_id": [ "a9d254e3-6157-4a0b-bff6-a07ca3aee7ac" ], "spl_set_id": [ "23cafaa1-34fe-4cef-960b-5f664ea32cb4" ], "package_ndc": [ "51316-945-06" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH" ] } } ] }