{"active_ingredient":["Active ingredients (in each 30 mL) Choline Salicylate (NSAID)* 870 mg Diphenhydramine HCI 50mg Phenylephrine HCl 10 mg"],"ask_doctor":["Ask a doctor before use if ▪ stomach bleeding warning applies to you ▪ you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems ▪ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes, thyroid disease, or glaucoma ▪ you have a cough with excessive phlegm (mucus) ▪ you have difficulty in urination due to enlargement of the prostate gland ▪ you have breathing problems such as emphysema or chronic bronchitis ▪ you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are ▪ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout, or arthritis. ▪ taking a diuretic ▪ under a doctor’s care for any serious condition ▪ taking sedatives or tranquilizers"],"do_not_use":["Do not use ▪ if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever / fever reducer. ▪ with any other drug 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 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. ▪ in children under 12 years of age"],"dosage_and_administration":["Directions do not exceed recommended dosage. do not take more than 6 doses in any 24-hour period. use enclosed dose cup keep dosage cup with product mL = milliliters adults and children 12 years of age and over: 30mL every 4 hours children under 12 years of age: do not use"],"effective_time":"20180628","id":"9871f8a8-da4a-4b65-8894-31155083b466","inactive_ingredient":["Inactive ingredients citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol"],"indications_and_usage":["Uses temporarily relieves these common cold and flu symptoms: ▪ nasal congestion ▪ minor aches and pains ▪ runny nose ▪ sneezing ▪ watery eyes ▪ sore throat ▪ headache ▪ 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."],"openfda":{},"other_safety_information":["Other information each 30mL contains: Sodium 16 mg tamper evident: Do not use if foil seal under cap is broken or missing. read all product information before using store at 68° to 86°F (20° to 30°C) avoid excessive heat and humidity"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 36800-888-08 Nighttime Cold & Flu Simple Relief 8 FL OZ (237mL) PRINCIPAL DISPLAY PANEL NDC 36800-888-08 Nighttime Cold & Flu Simple Relief 8 FL OZ (237mL) PRINCIPAL DISPLAY PANEL NDC 36800-888-08 Nighttime Cold & Flu Simple Relief 8 FL OZ (237mL) PRINCIPAL DISPLAY PANEL NDC 36800-888-08 Nighttime Cold & Flu Simple Relief 8 FL OZ (237mL)"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use salicylates (NSAIDs) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery."],"purpose":["Purpose Pain reliever/fever reducer Antihistamine Nasal decongestant nonsteroidal anti-inflammatory drug*"],"questions":["Questions or Comments? Call 1-888-423-0139"],"set_id":"aa264ce6-41a0-4099-86c7-5fcdc1bb9da3","spl_product_data_elements":["TopCare Nighttime Cold and Flu Simple Relief Choline Salicylate, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE CHOLINE SALICYLATE SALICYLIC ACID DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SACCHARIN SODIUM SORBITOL"],"spl_unclassified_section":["TopCare Nighttime Cold & Flu Simple Relief ( choline salicylate, diphenhydramine hcI , phenylephrine hcl ), solution Topco Associates LLC -- Topco Associates LLC. Nighttime Cold & Flu Simple Relief Drug Facts"],"stop_use":["Stop use and ask a doctor if ▪ an allergic reaction occurs. Seek medical help right away. ▪ pain, cough, or nasal congestion gets worse or lasts more than 7 days ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ ringing in the ears or a loss of hearing occurs ▪ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. ▪ nervousness, dizziness, or sleeplessness occurs ▪ you experience any of the following signs of stomach bleeding: ▪ feel faint ▪ vomit blood ▪ have bloody or black stools ▪ have stomach pain that does not get better"],"version":"1","warnings":["Warnings Reye's syndrome Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert Salicylates (NSAIDs) may cause a severe allergic reaction which may include: ▪ hives ▪ rash ▪ shock ▪ skin reddening ▪ facial swelling ▪ asthma (wheezing) Stomach bleeding warnings This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ▪ are age 60 or older ▪ have had stomach ulcers or bleeding problems ▪ take a blood thinning (anticoagulant) or steroid drug ▪ take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ▪ have 3 or more alcoholic drinks every day while using this product ▪ take more or for a longer time than directed 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 ▪ if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever / fever reducer. ▪ with any other drug 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 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. ▪ in children under 12 years of age Ask a doctor before use if ▪ stomach bleeding warning applies to you ▪ you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems ▪ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes, thyroid disease, or glaucoma ▪ you have a cough with excessive phlegm (mucus) ▪ you have difficulty in urination due to enlargement of the prostate gland ▪ you have breathing problems such as emphysema or chronic bronchitis ▪ you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are ▪ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout, or arthritis. ▪ taking a diuretic ▪ under a doctor’s care for any serious condition ▪ taking sedatives or tranquilizers When using this product ▪ do not use more than directed ▪ excitability may occur, especially in children ▪ marked drowsiness may occur ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ avoid alcoholic drinks ▪ be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if ▪ an allergic reaction occurs. Seek medical help right away. ▪ pain, cough, or nasal congestion gets worse or lasts more than 7 days ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ ringing in the ears or a loss of hearing occurs ▪ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. ▪ nervousness, dizziness, or sleeplessness occurs ▪ you experience any of the following signs of stomach bleeding: ▪ feel faint ▪ vomit blood ▪ have bloody or black stools ▪ have stomach pain that does not get better If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use salicylates (NSAIDs) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product ▪ do not use more than directed ▪ excitability may occur, especially in children ▪ marked drowsiness may occur ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ avoid alcoholic drinks ▪ be careful when driving a motor vehicle or operating machinery"]}