{"active_ingredient":["Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 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 • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, or emphysema • a sodium-restricted diet"],"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 • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • 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 an MAOI, ask a doctor or pharmacist before taking this product. • if you have ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions • take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use Other information • each 30 mL contains: sodium 41 mg • store at 20-25 ° C (68-77 ° F)"],"dosage_and_administration_table":["
adults & children 12 yrs & over30 mL every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
"],"effective_time":"20241030","id":"0ceee501-cd76-4a0f-9bcd-857cc358b190","inactive_ingredient":["Inactive ingredients anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum Questions? 1-800-719-9260"],"indications_and_usage":["Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • cough due to minor throat and bronchial irritation • cough to help you sleep • reduces swelling of nasal passages • promotes nasal and/or sinus drainage • temporarily restores freer breathing through the nose"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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":["CareOne Nighttime Severe Cold and Flu"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["American Sales Company"],"package_ndc":["41520-561-40"],"product_ndc":["41520-561"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1431245"],"spl_id":["0ceee501-cd76-4a0f-9bcd-857cc358b190"],"spl_set_id":["819d5c82-0240-4013-9904-c335bd65d03e"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2","04JA59TNSJ"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel CAREone ® Compare to the active ingredients in Vicks ® NyQuil ® Severe Cold & Flu NIGHTTIME SEVERE COLD & FLU Pain Reliever / Fever Reducer-Acetaminophen Cough Suppressant-Dextromethorphan HBr Antihistamine-Doxylamine Succinate Nasal Decongestant-Phenylephrine HCl Max Strength Relieves: Aches, Fever, Sore Throat Nasal/Sinus Congestion & Sinus Pressure Runny Nose Sneezing Cough OUR PHARMACISTS RECOMMEND Berry Flavor 12 FL OZ (355mL) 763-of-nighttime-severe-cold-and-flu"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant"],"questions":["Questions? 1-800-719-9260"],"set_id":"819d5c82-0240-4013-9904-c335bd65d03e","spl_product_data_elements":["CareOne Nighttime Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM clear, dark"],"stop_use":["Stop use and ask a doctor if • you get nervous, dizzy or sleepless • pain, nasal congestion, or cough 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 • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition."],"storage_and_handling":["Other information • each 30 mL contains: sodium 41 mg • store at 20-25 ° C (68-77 ° F)"],"version":"7","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. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • 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 an MAOI, ask a doctor or pharmacist before taking this product. • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, or emphysema • a sodium-restricted diet Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if • you get nervous, dizzy or sleepless • pain, nasal congestion, or cough 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 • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use."],"when_using":["When using this product • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness"]}