{"active_ingredient":["Active ingredients (in each packet) Acetaminophen, 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg"],"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"],"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."],"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
"],"effective_time":"20260902","id":"6274b9f7-e082-4696-9877-e1ba783d98c0","inactive_ingredient":["Inactive ingredients citric acid, FD& C yellow#6, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,"],"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"],"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."],"openfda":{"application_number":["M010"],"brand_name":["Nighttime Severe Cold and Cough"],"generic_name":["ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE"],"is_original_packager":[true],"manufacturer_name":["KROGER COMPANY"],"package_ndc":["41226-541-06"],"product_ndc":["41226-541"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1659960"],"spl_id":["6274b9f7-e082-4696-9877-e1ba783d98c0"],"spl_set_id":["7def6781-0881-46bf-ad7a-7a3f23a8d9f7"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40","04JA59TNSJ"]},"package_label_principal_display_panel":["Principal Display Kroger NIGHTTIME Severe Cold & Cough Honey Lemon 6 Packets"],"pregnancy_or_breast_feeding":["If pregnant or breast- feeding, ask a health care professional before use."],"purpose":["Purposes Pain reliever / fever reducer Antihistamine / Cough Suppressant Nasal Decongestant"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"7def6781-0881-46bf-ad7a-7a3f23a8d9f7","spl_product_data_elements":["Nighttime Severe Cold and Cough ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 MALTODEXTRIN POTASSIUM CHLORIDE SILICON DIOXIDE SUCRALOSE SUCROSE"],"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."],"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."],"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."],"version":"4","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."],"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"]}