{ "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": 5 } }, "results": [ { "spl_product_data_elements": [ "Nighttime Severe Cold and Cough ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 MALTODEXTRIN POTASSIUM CHLORIDE SILICON DIOXIDE SUCRALOSE SUCROSE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE" ], "active_ingredient": [ "Active ingredients (in each packet) Acetaminophen, 650 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 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": [ "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 a 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 a 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, asthma 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 symptoms do not get better or worsen pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, rash or headache that lasts. There could be signs of a serious condition." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast- feeding, ask a health care 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 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctor Age Dose children under 12 years of age do not use adults and children 12 years of age and over one packet 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
children under 12 years of agedo not use
adults and children 12 years of age and overone packet
" ], "storage_and_handling": [ "Other information each packet contains: potassium 6 mg aspartame free, sodium free store at room temperature. Protect from excessive heat and moisture." ], "inactive_ingredient": [ "Inactive ingredients citric acid, FD& C yellow#6, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose," ], "questions": [ "Questions or comments? 1-866-467-2748" ], "spl_unclassified_section": [ "Additional Information Listed On Other Panels Compare to the active ingredient in Theraflu Nighttime Severe Cold &Cough* NDC 41226-541-06 NIGHTTIME SEVERE COLD & COUGH Acetaminophen/ Pain Reliever/ Fever Reducer Diphenhydramine HCl / Antihistamine/ Cough Suppressant Phenylephrine HCl / Nasal Decongestant Relieves Cough Nasal Congestion Sore Throat Pain Headache Body ache Fever Runny nose Sneezing Honey Lemon Infused with Chamomile & White Tea Flavors 6 Packets 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. Distributed by: *This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Nighttime Severe Cold & Cough." ], "package_label_principal_display_panel": [ "Principal Display Kroger NIGHTTIME Severe Cold & Cough Honey Lemon 6 Packets" ], "set_id": "7def6781-0881-46bf-ad7a-7a3f23a8d9f7", "id": "3b87f717-d2f5-f93a-e063-6394a90a3447", "effective_time": "20250804", "version": "3", "openfda": { "application_number": [ "M010" ], "brand_name": [ "Nighttime Severe Cold and Cough" ], "generic_name": [ "ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE" ], "manufacturer_name": [ "KROGER COMPANY" ], "product_ndc": [ "41226-541" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DIPHENHYDRAMINE HYDROCHLORIDE", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1659960" ], "spl_id": [ "3b87f717-d2f5-f93a-e063-6394a90a3447" ], "spl_set_id": [ "7def6781-0881-46bf-ad7a-7a3f23a8d9f7" ], "package_ndc": [ "41226-541-06" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "TC2D6JAD40", "04JA59TNSJ" ] } } ] }