{"active_ingredient":["Active ingredients (in each Softgels) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg"],"dosage_and_administration":["Direction take only as directed do not exceed 4 doses per 24 hours adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use"],"dosage_and_administration_table":["<table width=\"100%\"><caption/><tbody><tr><td> adults &amp; children 12 yrs &amp; over</td><td> 2 softgels with water every 4 hrs</td></tr><tr><td> children 4 to under 12 yrs</td><td> ask a doctor</td></tr><tr><td> children under 4 yrs</td><td> do not use</td></tr></tbody></table>"],"effective_time":"20231021","id":"08337902-0be0-a579-e063-6294a90afc67","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 & bronchial irritation sore throat headache minor aches and pains fever"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Day-Time Cold and Flu Relief"],"generic_name":["ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN"],"is_original_packager":[true],"manufacturer_name":["HealthLife of USA"],"package_ndc":["69517-160-10"],"product_ndc":["69517-160"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1086997"],"spl_id":["08337902-0be0-a579-e063-6294a90afc67"],"spl_set_id":["c5f6cf22-2aaa-40e1-b7b3-448e55898d62"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","04JA59TNSJ"],"upc":["0369517160103"]},"other_safety_information":["Other information store at room temperature. TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION"],"package_label_principal_display_panel":["PACKAGE LABEL NDC 69517-160-10 10 Softgels Day-Time Cold & Flu Relief Acetaminophen, Phenylephrine, Dextromethorphan Aches, Fever & Sore Throat Nasal Congestion Cough *Compare to the active ingredients in Vicks Dayquil ® Night-time cold & flu"],"purpose":["Purpose Pain reliever/Fever reducer Cough suppressant Nasal decongestant"],"questions":["Questions or comments? 1-844-832-1138 M-F 9am-5pm EST"],"set_id":"c5f6cf22-2aaa-40e1-b7b3-448e55898d62","spl_product_data_elements":["Day-Time Cold and Flu Relief Acetaminophen, Phenylephrine, Dextromethorphan FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL METHYLPARABEN PROPYLPARABEN TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SN2"],"spl_unclassified_section":["If pregnant or breast-feeding, ask a health professional before use.","Distributed by: Health life of USA LLC Rahway, NJ 07065 www.healthlifeus.com *This product is not manufactured or distributed by Procter & Gamble, Distributor of Vicks Dayquil ®"],"version":"2","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product 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. 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 heart disease diabetes high blood pressure trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product, do not use more than directed. Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) 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."]}