{"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 ▪ 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 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":["
Age
Dose
adults and children 12 years of age and over
one packet
children under 12 years of age
do not use
"],"effective_time":"20260908","id":"7fd2aabb-24db-49c6-a943-74dc35da3877","inactive_ingredient":["Inactive ingredients citric acid, FD& C Yellow No. 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":["M012"],"brand_name":["Nighttime Severe Cold and Cough"],"generic_name":["ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE"],"is_original_packager":[true],"manufacturer_name":["RARITAN PHARMACEUTICALS INC"],"package_ndc":["68163-541-06"],"product_ndc":["68163-541"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1659960"],"spl_id":["7fd2aabb-24db-49c6-a943-74dc35da3877"],"spl_set_id":["9819155b-2713-42be-867e-16605e7643d0"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40","04JA59TNSJ"]},"package_label_principal_display_panel":["Display DRx Nighttime Severe Cold and Cough Honey Lemon Flavor"],"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":"9819155b-2713-42be-867e-16605e7643d0","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":["Principal Display Panels *Compare to the active ingredients in Theraflu ® Nighttime Severe Cold & Cough* NDC# 68163-541-06 Nighttime Severe Cold & Cough ACETAMINOPHEN PAIN RELIEVER/FEVER REDUER DIPHENHYDRAMINE HCl ANTIHISTAMINE/ COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT • Aspartame free • Sodium Free Relieves: Body Ache & Fever • Cough • Fever • Headache • Nasal Congestion • Runny Nose • Sneezing • Sore Throat Pain 6 PACKETS Honey Lemon Flavor Infused with Chamomile & White Tea Flavors TAMPER EVIDENT: DO NOT USE IF INNER SEALED PACKET IS TORN Manufactured by: Raritan Pharmaceuticals 8 Joanna Court East Brunswick, NJ 08816 *This product is not manufactured or distributed by GSK consumer Healthcare, owner of the registered trademark THERAFLU ® Nighttime Severe Cold & Cough."],"spl_unclassified_section_table":["
TAMPER EVIDENT: DO NOT USE IF INNER SEALED PACKET IS TORN
"],"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 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 room temperature. Protect from excessive heat and moisture."],"version":"8","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."],"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"]}