{ "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": 1 } }, "results": [ { "spl_product_data_elements": [ "Theraflu Severe Cold Relief Daytime Berry Burst Acetaminophen, Dextromethorphan HBr, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID ASPARTAME FD&C BLUE NO. 1 FD&C RED NO. 40 MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE, UNSPECIFIED FORM LECITHIN, SOYBEAN SUCROSE TRIBASIC CALCIUM PHOSPHATE Pink-purple Burst" ], "active_ingredient": [ "Active ingredients (in each packet) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg" ], "purpose": [ "Purposes Pain reliever/Fever reducer Cough suppressant Nasal decongestant" ], "indications_and_usage": [ "Uses • temporarily relieves these symptoms due to a cold: o minor aches and pains o minor sore throat pain o headache o nasal and sinus congestion o 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 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. • 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_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin" ], "when_using": [ "When using this product • do not exceed recommended dosage" ], "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 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": [ "AgeDoseadults and children12 years of age and overone packetchildren under12 years of agedo not use
" ], "other_safety_information": [ "Other information • each packet contains : potassium 10 mg, sodium 20 mg • phenylketonurics : contains phenylalanine 14 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 blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate" ], "questions": [ "Questions or Comments? call 1-855-328-5259" ], "spl_unclassified_section": [ "Additional Information READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.com 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. PA_620000000201493 HOT LIQUID THERAPY that relieves: Nasal and sinus congestion Cough Sore throat pain Headache Fever CARTON RECYCLE" ], "package_label_principal_display_panel": [ "Principal Display Panel HALEON NDC 0067-6800-02 MULTI-SYMPTOM COLD RELIEF THERAFLU SEVERE COLD RELIEF DAYTIME FORMULA ACETAMINOPHEN Paint Reliever/Fever Reducer Dextromethorphan HBr Cough Suppressant PHENYLEPHRINE HCl Nasal Decongestant Hot liquid therapy that relieves: / Nasal and sinus congestion / Cough / Sore throat pain / Headache / Fever Berry Burst Flavor 6 PACKETS Y:\\HAL-CH Drug Listing\\CH WORKING\\Theraflu Berry Burst 0067-6800\\Theraflu Severe Cold Relief Berry Burst 6 Packets.JPG" ], "set_id": "ebbb2f4b-ba84-40ad-96f6-60225119a33b", "id": "77b6db34-5ac4-46a5-9d6d-1c4cc83a9ba9", "effective_time": "20240227", "version": "3", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Theraflu Severe Cold Relief Daytime Berry Burst" ], "generic_name": [ "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE" ], "manufacturer_name": [ "Haleon US Holdings LLC" ], "product_ndc": [ "0067-6800" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXTROMETHORPHAN HYDROBROMIDE", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1659967" ], "spl_id": [ "77b6db34-5ac4-46a5-9d6d-1c4cc83a9ba9" ], "spl_set_id": [ "ebbb2f4b-ba84-40ad-96f6-60225119a33b" ], "package_ndc": [ "0067-6800-02" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ" ] } } ] }