{"active_ingredient":["Active ingredients (in each Softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg","Active ingredients (in each Softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg"],"dosage_and_administration":["Directions • take only as directed • do not exceed 8 softgels per 24 hrs adults & children 12 years of age & over 2 softgels with water every 4 hrs children 4 to under 12 years of age ask a doctor children under 4 years of age do not use","Directions • take only as directed • do not exceed 8 softgels per 24 hrs adults & children 12 years of age & over 2 softgels with water every 4 hrs children 4 to under 12 years of age ask a doctor children under 4 years of age do not use"],"dosage_and_administration_table":["<table width=\"40%\"><tbody><tr><td styleCode=\"Rrule Toprule\">adults &amp; children 12 years of age &amp; over</td><td styleCode=\"Botrule Lrule Toprule\">2 softgels with water every 4 hrs</td></tr><tr><td styleCode=\"Rrule Toprule\">children 4 to under 12 years of age</td><td styleCode=\"Botrule Lrule Toprule\">ask a doctor</td></tr><tr><td styleCode=\"Rrule Toprule\">children under 4 years of age</td><td styleCode=\"Botrule Lrule Toprule\">do not use</td></tr></tbody></table>","<table width=\"40%\"><tbody><tr><td styleCode=\"Botrule Rrule Toprule\">adults &amp; children 12 years of age &amp; over </td><td styleCode=\"Botrule Lrule Toprule\">2 softgels with water every 4 hrs </td></tr><tr><td styleCode=\"Botrule Rrule Toprule\">children 4 to under 12 years of age </td><td styleCode=\"Botrule Lrule Toprule\">ask a doctor </td></tr><tr><td styleCode=\"Botrule Rrule Toprule\">children under 4 years of age </td><td styleCode=\"Botrule Lrule Toprule\">do not use </td></tr></tbody></table>"],"effective_time":"20260820","id":"c85c730a-fe1e-4698-9af2-f543b56ae254","inactive_ingredient":["Inactive ingredients FD&C yellow no. 6, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, N-butyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.","Inactive ingredients D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, N-butyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide"],"indications_and_usage":["Uses • temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • minor aches & pains • headache • fever • sore throat • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to aid the bronchial passageways of bothersome mucus and make coughs more productive.","Uses • temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • cough to help you sleep • minor aches & pains • headache • fever • sore throat • runny nose & sneezing • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: 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.","Keep out of reach of children. Overdose warning: 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."],"openfda":{"application_number":["M012"],"brand_name":["COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ct"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["HyVee Inc"],"package_ndc":["42507-106-42"],"product_ndc":["42507-106"],"product_type":["HUMAN OTC DRUG"],"rxcui":["1297288","1656815","2634364"],"spl_id":["c85c730a-fe1e-4698-9af2-f543b56ae254"],"spl_set_id":["82ead335-d38e-40c3-8031-222bf985a302"]},"package_label_principal_display_panel":["Packaging Daytime&Nightime Cold&flu Daytime&Nightime Cold&flu2"],"purpose":["Purposes Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant","Purposes Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant"],"questions":["Questions or comments? 1-888-577-8033 Mon-Fri 8am-4pm EST","Questions or comments? 1-888-577-8033 Mon-Fri 8am-4pm EST"],"set_id":"82ead335-d38e-40c3-8031-222bf985a302","spl_product_data_elements":["COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ct Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, Doxylamine succinate HyVee Daytime Severe Cold and Flu SOFTGEL Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN ISOPROPYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES BUTYL ALCOHOL POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN TITANIUM DIOXIDE A13 HyVee Nighttime Severe Cold and Flu SOFTGEL Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN ISOPROPYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES BUTYL ALCOHOL POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL SORBITAN TITANIUM DIOXIDE A07"],"spl_unclassified_section":["DAYTIME SEVERE COLD AND FLU RELIEF Drug Facts","NIGHTTIME SEVERE COLD AND FLU RELIEF Drug Facts","*Compare to the Active Ingredients of Vicks ® DayQuil™ Severe Cold & Flu LiquiCaps™ Antihistamine Free *Compare to the Active Ingredients of Vicks ® NyQuil™ Severe Cold & Flu LiquiCaps™ *These products are not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademarks Vicks ® DayQuil ™ , NyQuil™ Severe Liquicaps™. TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION DO NOT TAKE THESE PRODUCTS AT THE SAME TIME DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY WEST DES MOINES, IA 50266 PRODUCT OF INDIA SATISFACTION GUARANTEED OR PURCHASE PRICE REFUNDED FOR INFORMATION CALL 1-800-289-8343 www.hy-vee.com"],"storage_and_handling":["Other information • contains FD&C yellow no.6 • store at 20-25°C (68-77°F) • protect from light, heat, and moisture","Other information • store at 20-25°C (68-77°F) • protect from light, heat, and moisture"],"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 • 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 such 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 • 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: 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.","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 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 • heart disease • high blood pressure • thyroid disease • diabetes • 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, and tranquilizers may increase drowsiness 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. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning: 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."]}