{"active_ingredient":["Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin."],"do_not_use":["Do not use with any other product 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."],"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 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use"],"dosage_and_administration_table":["<table width=\"75%\"><col width=\"50%\" align=\"left\" valign=\"top\"/><col width=\"50%\" align=\"left\" valign=\"top\"/><tbody><tr><td align=\"left\" styleCode=\"Botrule Rrule\"><content styleCode=\"bold\">adults and children 12 years and over</content></td><td align=\"left\" styleCode=\"Botrule\">take 2 softgels with water every 4 hours</td></tr><tr><td align=\"left\" styleCode=\"Botrule Rrule\"><content styleCode=\"bold\">children 4 to under 12 years</content></td><td align=\"left\" styleCode=\"Botrule\">ask a doctor</td></tr><tr styleCode=\"Botrule Last\"><td align=\"left\" styleCode=\"Rrule\"><content styleCode=\"bold\">children under 4 years</content></td><td align=\"left\">do not use</td></tr></tbody></table>"],"effective_time":"20240330","id":"14dd3fc0-c0c1-38d3-e063-6394a90a3dcc","inactive_ingredient":["Inactive ingredients FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, methyl paraben, propyl paraben, titanium dioxide"],"indications_and_usage":["Uses Temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever sore throat"],"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":["DAYTIME COLD AND FLU RELIEF"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Advanced Rx LLC"],"package_ndc":["80513-303-50"],"product_ndc":["80513-303"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1086997"],"spl_id":["14dd3fc0-c0c1-38d3-e063-6394a90a3dcc"],"spl_set_id":["38299cf3-e884-4676-8cc4-6dd64e7d023c"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","04JA59TNSJ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 80513-303-50 Compare to the active ingredients in Vicks ® DayQuil ® Cold & Flu LiquiCaps ® 50 Softgels NON-DROWSY DAYTIME COLD & FLU RELIFE Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr Pain Reliever Fever Reducer Cough Suppressant Nasal Decongestant label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant"],"questions":["Questions? 1-800-630-8895"],"set_id":"38299cf3-e884-4676-8cc4-6dd64e7d023c","spl_product_data_elements":["DAYTIME COLD AND FLU RELIEF Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride FD&C YELLOW NO. 6 FD&C RED NO. 40 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL METHYLPARABEN PROPYLPARABEN TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SN2"],"spl_unclassified_section":["Drug Facts","Distributed by: Advanced Rx 1942 NE 163rd St, North Miami Beach, FL 33162 U.S.A. *This product is not manufactured or distributed by the owner of the registered trademark Vicks ® DayQuil ® ​Cold & Flu LiquiCaps ®"],"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 store at room temperature. DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED."],"version":"1","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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly."],"when_using":["When using this product, do not use more than directed."]}