{"active_ingredient":["Active ingredients (in each packet) Acetaminophen 650 mg Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride 10 mg"],"ask_doctor":["Ask a doctor before use if you have ▪ liver disease ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ glaucoma ▪ a sodium-restricted diet ▪ 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 ▪ the blood thinning drug warfarin"],"do_not_use":["Do not use ▪ in a child under 4 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 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; not to exceed 5 packets in 24 hours or as directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor 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 4 years of agedo not use
children 4 to under 12 years of agedo not use unless directed by a doctor
adults and children 12 years of age and overone packet
"],"effective_time":"20260216","id":"9d200774-ba9a-4dd1-aa5f-45e2907f7faa","inactive_ingredient":["Inactive ingredients citric acid, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose, yellow#6"],"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":{},"package_label_principal_display_panel":["Principal Display 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":"6c133d12-773e-466e-aaea-d165a7d1df81","spl_product_data_elements":["Nighttime Severe Cough and Cold ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID MALTODEXTRIN POTASSIUM CHLORIDE SILICON DIOXIDE SUCRALOSE SUCROSE FD&C YELLOW NO. 6 LEMON"],"spl_unclassified_section":["Additional Information Listed On Other Panels LEADER NDC 70000-0128-1 Nighttime Severe Cold &Cough Acetaminophen Diphenhydramine HCl Phenylephrine HCl Pain reliever/ Fever reducer Antihistamine/ Cough suppressant Nasal Decongestant Honey Lemon Infused with Chamomile & White Tea Flavors Naturally and Artificially Flavored COMPARE TO THERAFLU ® NIGHTTIME SEVERE COLD & COUGH* active ingredients * 100% Money Back Guarantee Relieves: Nasal Congestion, Cough, Runny Nose, Sneezing, Body Ache, Sore Throat Pain, Headache & Fever 6 PACKETS READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE, KEEP CARTON FOR REFERENCE, DO NOT DISCARD, NIGHTTIME Severe Cough & Cold Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to care™ since 1979 TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN. ©2017 CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark 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 ▪ store at controlled room temperature 20 o -25 o C (68 o -77 o F). 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 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"]}