{ "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": 6 } }, "results": [ { "spl_product_data_elements": [ "Theraflu Severe Cold relief Nighttime Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID ASPARTAME FD&C YELLOW NO. 6 MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE, UNSPECIFIED FORM LECITHIN, SOYBEAN SUCROSE TRIBASIC CALCIUM PHOSPHATE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE white to off-white yellow, beige/brown granules Green Tea & Citrus" ], "active_ingredient": [ "Active ingredients (in each packet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg" ], "purpose": [ "Purposes Pain reliever/Fever reducer Antihistamine/cough suppressant Nasal decongestant" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation 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. with any other product containing diphenhydramine, even one used on the skin 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 glaucoma 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 sedatives or tranquilizers taking the blood thinning drug warfarin When using this product do not exceed recommended dosage 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 nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or last more than 7 days 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. 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. with any other product containing diphenhydramine, even one used on the skin 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 heart disease high blood pressure thyroid disease diabetes glaucoma 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 sedatives or tranquilizers taking the blood thinning drug warfarin" ], "when_using": [ "When using this product do not exceed recommended dosage 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 nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or last more than 7 days 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. 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 4 hours, while symptoms persist. Do not take more than 6 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. Consumer 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": [ "
AgeDose
adults and children 12 years of age and overone packet
children under 12 years of agedo not use
" ], "other_safety_information": [ "Other information each packet contains : potassium 10 mg, sodium 23 mg phenylketonurics : contains phenylalanine 13 mg per packet store at controlled room temperature 20-25°C (68-77°F). Protect product from heat and moisture." ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, FD&C yellow no. 6, flavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate" ], "questions": [ "Questions or Comments? call 1-800-328-5259" ], "spl_unclassified_section": [ "Generic Section TAMPER EVIDENT INNER UNIT DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN 1-855-328-5259 Distributed by: GSK Consumer Healthcare Warren, NJ 07059 ©2022 GSK group of companies or its licensor. Trademarks are owned by or licensed to the GSK group of companies. 62000000075407 HOT LIQUID THERAPY that relieves: Nasal and sinus congestion Cough Sore throat pain Headache Runny nose Fever PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.com *Temporarily controls cough to help you rest. This is not a sleep aid CARTON RECYCLE" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0067-6801-02 MULTI-SYMPTOM COLD RELIEF THERAFLU SEVERE COLD RELIEF NIGHTTIME ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER DIPHENHYDRAMINE HCl ANTIHISTAMINE/COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT HELPS YOU REST* Hot liquid therapy that relieves: / Nasal and sinus congestion / Cough / Sore throat pain / Headache / Runny nose / Fever Citrus & Green Tea 6 PACKETS Theraflu Sever Cold Relief Citrus Green Tea 6 Packets" ], "set_id": "0d3b1bea-e2ca-4e07-8ae5-60627d230c96", "id": "132cdb61-2615-2863-e063-6394a90a7e5a", "effective_time": "20240308", "version": "2", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Theraflu Severe Cold relief Nighttime" ], "generic_name": [ "ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE" ], "manufacturer_name": [ "Haleon US Holdings LLC" ], "product_ndc": [ "0067-6801" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DIPHENHYDRAMINE HYDROCHLORIDE", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1659175" ], "spl_id": [ "132cdb61-2615-2863-e063-6394a90a7e5a" ], "spl_set_id": [ "0d3b1bea-e2ca-4e07-8ae5-60627d230c96" ], "package_ndc": [ "0067-6801-02" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "TC2D6JAD40", "04JA59TNSJ" ] } } ] }