{"active_ingredient":["Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg"],"dosage_and_administration":["Directions -Do not take more than directed (see Overdose warning) do not exceed more than 8 softgels in any 24 hr- period - adults & children 12 yrs & older: take 2 Softgels every 4 hrs children under 12 yrs of age - Do not use."],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><paragraph><content styleCode=\"bold\">Directions</content> -Do not take more than directed (see Overdose warning) </paragraph><paragraph/><list listType=\"unordered\"><item>do not exceed more than 8 softgels in any 24 hr- period -</item><item>adults &amp; children 12 yrs &amp; older: take 2 Softgels every 4 hrs</item><item>children under 12 yrs of age - Do not use.</item></list></td></tr></tbody></table>"],"effective_time":"20250215","id":"2d004249-e006-72fa-e063-6394a90a14c1","inactive_ingredient":["FD&C Blue No. 1, gelatin, glycerin,polyethylene glycol , povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution titanium dioxide,"],"indications_and_usage":["temporarily relieves common cold/flu symptoms: nasal congestion, cough, nasal congestion, minor aches and pains, sore throat, headache, runny nose and sneezing temporarily reduces fever controls cough to help you get to sleet"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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":{},"package_label_principal_display_panel":["8 ct"],"purpose":["Purpose Pain reliever/Fever reducer Cough suppressant Antihistamine Nasal decongestant"],"set_id":"9dff2418-031c-1308-e053-2995a90accb4","spl_product_data_elements":["MAXIMUM STRENGTH NIGHTTIME COLD AND FLU ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 1 GELATIN POVIDONE PROPYLENE GLYCOL POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL GLYCERIN SHELLAC TITANIUM DIOXIDE CAPSULE SHAPED 72"],"version":"3","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 daily while using this product Allergy Alert : acetaminophen may cause severe skin reactions. Symptoms may include: Skin reddening Blisters Rash Sore troat 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."]}