{"active_ingredient":["Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg Purpose Pain reliever/fever reducer Cough suppressant Antihistamine"],"ask_doctor":["Ask a doctor before use if you have ▪ liver disease ▪ glaucoma ▪ cough that occurs with too much phlegm (mucus) ▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema ▪ trouble urinating due to enlarged prostate gland"],"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."],"dosage_and_administration":["Directions ▪ take only as directed ▪ do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use"],"dosage_and_administration_table":["
adults & children 12 yrs & over2 softgels with water every 6 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
"],"effective_time":"20260121","id":"f466fc0e-3384-4884-832e-99bf1fdcf899","inactive_ingredient":["Inactive ingredients FD&C Blue No. 1, D&C Yellow No. 10, gelatin, glycerin, polyethylene glycol 400, polyvinyl pyrrolidone, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves common cold/flu symptoms: ▪ cough due to minor throat & bronchial irritation ▪ sore throat ▪ headache ▪ minor aches & pains ▪ fever ▪ runny nose & sneezing"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["DRX CHOICE NIGHTTIME COLD and FLU RELIEF"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Raritan Pharmaceuticals Inc."],"package_ndc":["68163-062-10"],"product_ndc":["68163-062"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1094549"],"spl_id":["f466fc0e-3384-4884-832e-99bf1fdcf899"],"spl_set_id":["f466fc0e-3384-4884-832e-99bf1fdcf899"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2"],"upc":["0368163062106"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL *Compare to the active ingredients in Vicks® NyQuil™ Cold & Flu LiquiCaps™ DRx Choice® Nighttime Cold & flu relief Acetaminophen – Pain Reliever/Fever Reducer Doxylamine Succinate – Antihistamine Dextromethorphan HBr – Cough Suppressant Headache, Fever, Sore Throat, Minor Aches & Pains Sneezing, Runny Nose, Cough 10 softgels DRx Choice nighttime cold & flu relief 10 softgels"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer Cough suppressant Antihistamine"],"questions":["Questions or comments? 1-866-467-2748"],"set_id":"f466fc0e-3384-4884-832e-99bf1fdcf899","spl_product_data_elements":["DRX CHOICE NIGHTTIME COLD and FLU RELIEF Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE FD&C BLUE NO. 1 D&C YELLOW NO. 10 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL SORBITOL TITANIUM DIOXIDE RP062"],"spl_unclassified_section":["Drug Facts","TAMPER EVIDENT: This package is safety-sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.","Distributed by: Raritan Pharmaceuticals 8 Joanna Court East Brunswick, NJ 08816"],"stop_use":["Stop use and ask a doctor if ▪ pain 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 • store at room temperature"],"version":"1","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ▪ more than 8 softgels in 24 hours, which is the maximum daily amount for this product ▪ 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. Ask a doctor before use if you have ▪ liver disease ▪ glaucoma ▪ cough that occurs with too much phlegm (mucus) ▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema ▪ trouble urinating due to enlarged prostate gland 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, & tranquilizers may increase drowsiness Stop use and ask a doctor if ▪ pain 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"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, & tranquilizers may increase drowsiness"]}