{"active_ingredient":["Drug Facts 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 • thyroid disease • high blood pressure • trouble urinating due to enlarged prostate gland • heart disease • diabetes • 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 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 4 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":["
adults & children 12 years and over
2 softgels with water every 4 hours
children 4 to under 12 years
ask a doctor
children under 4 years
do not use
"],"effective_time":"20260330","id":"4e448fd0-cb6c-b69b-e063-6394a90afde8","inactive_ingredient":["Other information • store at room temperature 20-25°C (68-77°F) • avoid excessive heat","Inactive ingredients FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, 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 & pains • fever"],"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 Daytime Cold and Flu"],"generic_name":["ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCL 5 MG"],"is_original_packager":[true],"manufacturer_name":["Farmacias De Similares TX LLC"],"package_ndc":["85786-601-12"],"product_ndc":["85786-601"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1086997"],"spl_id":["4e448fd0-cb6c-b69b-e063-6394a90afde8"],"spl_set_id":["4e448fd0-cb6b-b69b-e063-6394a90afde8"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","ACETAMINOPHEN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","362O9ITL9D","04JA59TNSJ"]},"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 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant"],"purpose_table":["
Acetaminophen 325 mg
Pain reliever / fever reducer
Dextromethorphan HBr 10 mg
Cough suppressant
Phenylephrine HCl 5 mg
Nasal decongestant
"],"questions":["Questions or comments? 855-280-1079"],"set_id":"4e448fd0-cb6b-b69b-e063-6394a90afde8","spl_product_data_elements":["Dr. Simi Daytime Cold and Flu Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg GLYCERIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN FD&C RED NO. 40 GELATIN POVIDONE PROPYLENE GLYCOL WATER ACETAMINOPHEN ACETAMINOPHEN TITANIUM DIOXIDE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SORBITOL POLYETHYLENE GLYCOL, UNSPECIFIED FD&C YELLOW NO. 6 SORBITAN 603 Oblong softgel capsule"],"spl_unclassified_section":["Principal Display Panel NDC: 85786-601-12 DR. SIMI Daytime Cold & Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl Pain Reliever / Fever Reducer Cough Suppressant & Nasal Decongestant Multi-Symptom Relief. Aches, Fever, Sore Throat, Cough, Nasal Congestion, Sinus Pressure 12 Softgels *Compare to the active ingredients in Vicks® DayQuil™ Cold & Flu LiquiCaps™ *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil™ LiquiCap™. 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, cough, or nasal congestion gets worse or lasts more than 7 days • nervousness, dizziness, or sleeplessness occur • 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 • thyroid disease • high blood pressure • trouble urinating due to enlarged prostate gland • heart disease • diabetes • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma 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 • pain, cough, or nasal congestion gets worse or lasts more than 7 days • nervousness, dizziness, or sleeplessness occur • 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 use more than directed."]}