{"active_ingredient":["ACTIVE INGREDIENT (IN EACH SOFTGEL) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine Succinate 6.25 mg"],"dosage_and_administration":["DIRECTIONS take only as directed do not exceed 4 doses per 24 hours adults and children 12 years and over take 2 softgels with water every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>adults and children 12 years and over</td><td>take 2 softgels with water every 6 hours</td></tr><tr><td>children 4 to under 12 years</td><td>ask a doctor</td></tr><tr><td>children under 4 years</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20240913","id":"220d53b9-4208-092d-e063-6394a90a9b0a","inactive_ingredient":["INACTIVE INGREDIENTS D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, polysorbate, povidone, propylene glycol, purified water, sorbitol 70% solution, sorbitol sorbitan solution, titanium dioxide."],"indications_and_usage":["USES Temporarily relieves common cold and flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing"],"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 (1-800-222-1222) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Advanced Rx LLC"],"package_ndc":["80513-302-50"],"product_ndc":["80513-302"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1094549"],"spl_id":["220d53b9-4208-092d-e063-6394a90a9b0a"],"spl_set_id":["fa1b60b1-49cb-1211-e053-6394a90a0a46"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE","ACETAMINOPHEN"],"unii":["9D2RTI9KYH","V9BI9B5YI2","362O9ITL9D"],"upc":["0380513000606"]},"package_label_principal_display_panel":["PDP DF1 DF2"],"purpose":["PURPOSE Pain reliever/fever reducer Cough suppressant Antihistamine"],"questions":["QUESTIONS? call toll-free 1-800-630-8895"],"set_id":"fa1b60b1-49cb-1211-e053-6394a90a0a46","spl_product_data_elements":["NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE PROPYLENE GLYCOL SORBITAN FD&C BLUE NO. 1 POLAWAX POLYSORBATE D&C YELLOW NO. 10 POVIDONE TITANIUM DIOXIDE GLYCERIN GELATIN TYPE B BOVINE (160 BLOOM) POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL SOLUTION DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ACETAMINOPHEN ACETAMINOPHEN IS2"],"storage_and_handling":["OTHER INFORMATION store at room temperature"],"version":"4","warnings":["WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses 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 products containing acetaminophen (prescription or non-prescription). 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 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 an 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 exceed recommended dosage 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 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."]}