{"active_ingredient":["Active ingredients (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 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use"],"dosage_and_administration_table":["<table width=\"50%\"><tbody><tr><td styleCode=\"Botrule Rrule Toprule\"> adults &amp; children 12 yrs &amp; over</td><td styleCode=\"Botrule Lrule Toprule\"> 2 softgels with water every 6 hrs</td></tr><tr><td styleCode=\"Botrule Rrule Toprule\"> children 4 to under 12 yrs</td><td styleCode=\"Botrule Lrule Toprule\"> ask a doctor</td></tr><tr><td styleCode=\"Botrule Rrule Toprule\"> children under 4 yrs</td><td styleCode=\"Botrule Lrule Toprule\"> do not use</td></tr></tbody></table>"],"effective_time":"20240930","id":"6dc00620-a669-492f-b1e7-98ba9f60f34d","inactive_ingredient":["Inactive ingredients D&C Yellow no. 10, edible printing ink, FD&C blue no. 1, gelatin (bovine), glycerin, polyethylene glycol 400, povidone K-17, propylene glycol, purified water, sorbitol sorbitan solution"],"indications_and_usage":["Uses temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever • runny nose & sneezing"],"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."],"openfda":{"application_number":["M012"],"brand_name":["meijer Nighttime Cold and Flu SOFTGEL"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["Meijer, Inc."],"package_ndc":["79481-0808-4"],"product_ndc":["79481-0808"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1094549"],"spl_id":["6dc00620-a669-492f-b1e7-98ba9f60f34d"],"spl_set_id":["1bec5167-5fc5-2405-e063-6294a90a5358"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE"],"unii":["362O9ITL9D","9D2RTI9KYH","V9BI9B5YI2"],"upc":["0713733981361"]},"package_label_principal_display_panel":["Packaging Nighttime Cold and Flu SOFTGEL"],"purpose":["Purpose Pain reliever/fever reducer Cough suppressant Antihistamine"],"questions":["Questions or comments? 1-888-577-8033 Monday - Friday 8am - 4pm EST"],"set_id":"1bec5167-5fc5-2405-e063-6294a90a5358","spl_product_data_elements":["meijer Nighttime Cold and Flu SOFTGEL Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN TYPE B BOVINE (230 BLOOM) GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K17 PROPYLENE GLYCOL WATER SORBITOL SORBITAN 808"],"spl_unclassified_section":["Drug Facts","COMPARE TO VICKS ® NYQUIL ™ COLD & FLU LIQUICAPS™ ACTIVE INGREDIENTS* *This product is not manufactured or distributed by The Procter & Gamble Co., owner of the trademarks Vicks ® , NyQuil™ and LiquiCaps™. DIST. BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 WWW.MEIJER.COM PRODUCT OF UNITED ARAB EMIRATES READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING."],"spl_unclassified_section_table":["<table width=\"100%\"><tbody><tr styleCode=\"First Last\"><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\"><content styleCode=\"bold\"> READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION</content></td></tr></tbody></table>","<table width=\"100%\"><tbody><tr styleCode=\"First Last\"><td styleCode=\"Lrule Rrule Toprule Botrule\" align=\"center\"><content styleCode=\"bold\"> TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.</content></td></tr></tbody></table>"],"storage_and_handling":["Other information • store at room temperature between 20°-25°C (68°-77°F) • protect from light, heat, and moisture"],"version":"3","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 • 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 • 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. 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."]}