{"active_ingredient":["Drug Facts Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg"],"ask_doctor":["Ask a doctor before use if you have ■ liver disease ■ 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_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are ■ taking sedatives or tranquilizers ■ taking the blood thinning drug warfarin"],"do_not_use":["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."],"dosage_and_administration":["Directions ■ take only as directed (see Warnings) ■ do not exceed 4 doses per 24 hrs adults & children 12 years and over 2 softgels with water every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use ■ When using other daytime or nighttime products, carefully read each label to ensure correct dosing"],"dosage_and_administration_table":["<table border=\"0\" width=\"40%\"><tbody><tr><td>adults &amp; children 12 years and over</td><td>2 softgels with water every 6 hours</td></tr><tr><td>children 4 to under 12 years</td><td>ask a doctor</td></tr><tr><td>children under 4 years</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20260330","id":"4e5772ee-586d-6191-e063-6294a90a132d","inactive_ingredient":["Inactive ingredients D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide"],"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. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children, even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["Dr. Simi Nighttime Cold and Flu"],"generic_name":["ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MG"],"is_original_packager":[true],"manufacturer_name":["Farmacias De Similares TX LLC"],"package_ndc":["85786-602-24"],"product_ndc":["85786-602"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1094549"],"spl_id":["4e5772ee-586d-6191-e063-6294a90a132d"],"spl_set_id":["4e5772ee-586c-6191-e063-6294a90a132d"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE","ACETAMINOPHEN"],"unii":["9D2RTI9KYH","V9BI9B5YI2","362O9ITL9D"]},"other_safety_information":["Other information ■ Store at room temperature 20-25°C (68-77°F) ■ avoid excessive heat"],"package_label_principal_display_panel":["Carton labeling Label - Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Acetaminophen 325 mg Pain reliever/ fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine"],"purpose_table":["<table border=\"0\" width=\"40%\"><tbody><tr><td>Acetaminophen 325 mg</td><td>Pain reliever/ fever reducer</td></tr><tr><td>Dextromethorphan HBr 15 mg</td><td>Cough suppressant</td></tr><tr><td>Doxylamine succinate 6.25 mg</td><td>Antihistamine</td></tr></tbody></table>"],"questions":["Questions or comments? 855-280-1079"],"set_id":"4e5772ee-586c-6191-e063-6294a90a132d","spl_product_data_elements":["Dr. Simi Nighttime Cold and Flu Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Doxylamine Succinate 6.25 mg POLYETHYLENE GLYCOL, UNSPECIFIED DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN FD&C BLUE NO. 1 GELATIN GLYCERIN WATER SORBITOL PROPYLENE GLYCOL TITANIUM DIOXIDE DOXYLAMINE SUCCINATE DOXYLAMINE D&C YELLOW NO. 10 SORBITAN POVIDONE ACETAMINOPHEN ACETAMINOPHEN Oblong softgel capsule 604"],"spl_unclassified_section":["Principal Display Panel NDC: 85786-602-24 DR. SIMI Nighttime Cold & Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate Pain Reliever / Fever Reducer Cough Suppressant & Antihistamine Multi-Symptom Relief: Aches, Fever, Sore Throat, Cough, Sneezing & Runny Nose 24 Softgels *Compare to the active ingredients in Vicks® NyQuil™ Cold & Flu Nighttime Relief LiquiCaps™ *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademarks Vicks® NyQuil™ LiquiCaps™. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: FARMACIAS DE SIMILARES TX LLC 800 Brazos St Ste 260, Austin, TX, 78701, USA customerservice@drsimi.com www.drsimi.com"],"stop_use":["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."],"version":"1","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 8 softgels 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 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 ■ 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 exceed recommended dosage ■ 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 & 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. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children, even if you do not notice any signs or symptoms."],"when_using":["When using this product ■ do not exceed recommended dosage ■ 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 & tranquilizers may increase drowsiness"]}