{ "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": [ "Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl THERAFLU MULTI-SYMPTOM SEVERE COLD ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID ASPARTAME D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE, UNSPECIFIED FORM SUCROSE TRIBASIC CALCIUM PHOSPHATE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE GREEN TEA & HONEY LEMON FLAVORS THERAFLU NIGHTTIME SEVERE COLD AND COUGH ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID ASPARTAME D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE, UNSPECIFIED FORM SUCROSE TRIBASIC CALCIUM PHOSPHATE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HONEY LEMON INFUSED WITH CHAMOMILE & WHITE TEA FLAVORS Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl THERAFLU MULTI-SYMPTOM SEVERE COLD ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID ASPARTAME D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE, UNSPECIFIED FORM SUCROSE TRIBASIC CALCIUM PHOSPHATE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE GREEN TEA & HONEY LEMON FLAVORS THERAFLU NIGHTTIME SEVERE COLD AND COUGH ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl ASPARTAME D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE, UNSPECIFIED FORM SUCROSE TRIBASIC CALCIUM PHOSPHATE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID HONEY LEMON INFUSED WITH CHAMOMILE & WHITE TEA FLAVORS" ], "spl_unclassified_section": [ "Theraflu Multi-Symptom Severe Cold", "Other information each packet contains: potassium 10 mg, sodium 19 mg phenylketonurics: contains phenylalanine 20 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.", "Theraflu Nighttime Severe Cold & Cough", "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.", "Additional Information DO NOT TAKE THE MULTI-SYMPTOM AND NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org 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 ©2019 GSK group of companies or its licensor. Trademarks are owned by or licensed to the GSK group of companies. READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD. DO NOT TAKE THE MULTI-SYMPTOM AND NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD. DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF MULTI-SYMPTOM PRODUCT UNLESS DIRECTED BY YOUR DOCTOR." ], "active_ingredient": [ "Active ingredients (in each packet) Acetaminophen 500 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg", "Active ingredients (in each packet) Acetaminophen 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg" ], "purpose": [ "Purposes Pain Reliever/fever reducer Cough suppressant Nasal decongestant", "Purpose s 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 cough due to minor throat and bronchial irritation temporarily reduces fever", "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. 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 trouble urinating due to an enlarged prostate gland 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 When using this product do not exceed recommended dosage 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 lasts 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.", "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 lasts 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. 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.", "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 trouble urinating due to an enlarged prostate gland 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 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 the blood thinning drug warfarin", "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", "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 lasts more than 7 days cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.", "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 lasts 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.", "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.", "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. 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.", "Directions do not use more than directed take every 4 hours, while symptoms persist. Do not take more than 5 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": [ "
AgeDose
adults and children 12 years of age and overone packet
children under 12 years of agedo not use
", "
AgeDose
adults and children 12 years of age and overone packet
children under 12 years of agedo not use
" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate", "Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate" ], "questions": [ "Questions or comments? call 1-855-328-5259", "Questions or comments? call 1-855-328-5259" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0067-7919-12 THERAFLU MULTI-SYMPTOM SEVERE COLD Acetaminophen Pain Reliever/Fever Reducer Dextromethorphan HBr Cough Suppressant Phenylephrine HCl Nasal Decongestant Cough Nasal Congestion Sore Throat Pain Headache Body Ache Fever TEA INFUSIONS GREEN TEA & HONEY LEMON FLAVORS MULTI-SYMPTOM 6 PACKETS NIGHTTIME SEVERE COLD & COUGH Acetaminophen Pain Reliever/Fever Reducer Diphenhydramine HCl Antihistamine/Cough Suppressant Phenylephrine HCl Nasal Decongestant Cough Nasal Congestion Sore Throat Pain Headache Body Ache Fever Runny Nose Sneezing HONEY LEMON INFUSED WITH CHAMOMILE & WHITE TEA FLAVORS NIGHTTIME 6 PACKETS USE AS DIRECTED 12 TOTAL PACKETS gsk 13469 Theraflu Multi-Symptom Severe Cold and Night Severe Cold & Cough copack 12 count carton.", "Principal Display Panel NDC 0067-8200-01 THERAFLU MULTI-SYMPTOM SEVERE COLD Acetaminophen Pain Reliever/Fever Reducer Dextromethorphan HBr Cough Suppressant Phenylephrine HCl Nasal Decongestant Cough Nasal Congestion Sore Throat Pain Headache Body Ache Fever TEA INFUSIONS GREEN TEA & HONEY LEMON FLAVORS MULTI-SYMPTOM 18 PACKETS NIGHTTIME SEVERE COLD & COUGH Acetaminophen Pain Reliever/Fever Reducer Diphenhydramine HCl Antihistamine/Cough Suppressant Phenylephrine HCl Nasal Decongestant Cough Nasal Congestion Sore Throat Pain Headache Body Ache Fever Runny Nose Sneezing HONEY LEMON INFUSED WITH CHAMOMILE & WHITE TEA FLAVORS NIGHTTIME 6 PACKETS USE AS DIRECTED 24 TOTAL PACKETS gsk 13471 Theraflu Multi-Symptom Severe Cold and Nighttime Severe Cold & Cough copack 24 count carton" ], "set_id": "b06b64c5-dbb4-4ef5-af18-3d7d4979c02f", "id": "15bf1214-572a-f6b6-e063-6394a90ab0cb", "effective_time": "20240410", "version": "8", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough" ], "generic_name": [ "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL" ], "manufacturer_name": [ "Haleon US Holdings LLC" ], "product_ndc": [ "0067-8200", "0067-7919" ], "product_type": [ "HUMAN OTC DRUG" ], "rxcui": [ "1189316", "1659960", "2640034" ], "spl_id": [ "15bf1214-572a-f6b6-e063-6394a90ab0cb" ], "spl_set_id": [ "b06b64c5-dbb4-4ef5-af18-3d7d4979c02f" ], "package_ndc": [ "0067-7919-12", "0067-6426-01", "0067-6426-06", "0067-7918-01", "0067-7918-06", "0067-8200-01" ], "is_original_packager": [ true ] } } ] }