{"active_ingredient":["DRUG FACTSActive ingredients (in each 5 mL tsp) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCL, USP 5 mg"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant. When using this product do not use more than directed. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema"],"dosage_and_administration":["Directions Do not take more than 6 doses in any 24 hour period This adult strength product is not intended for use in children under 12 years of age Age - adults and children 12 years and over Dose - 2 teaspoons every 4 hours Age - children under 12 Dose - do not use"],"effective_time":"20241220","id":"1d6a3285-0fe9-4591-8d3b-db08493c7c92","inactive_ingredient":["Inactive ingredients anhydrous citric acid, FD and C yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum"],"indications_and_usage":["Uses help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold • nasal congestion • cough due to minor throat and bronchial irritation"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["Tukol X-Pecto Miel Multi Symptom Cold"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Genomma Lab USA, Inc."],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["50066-533-24"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["50066-533"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1044949"],"spl_id":["1d6a3285-0fe9-4591-8d3b-db08493c7c92"],"spl_set_id":["b9d32964-5bd7-44b0-be98-827d5310ed4f"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"other_safety_information":["Other information each teaspoon contains: sodium 3 mg store at 20‐25 ° C (68‐77 ° F). Do not refrigerate. dosage cup provided"],"package_label_principal_display_panel":["Tukol X-PECTO MIEL Cough & Cold product label Tukol ® X-PECTO MIEL DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL Cough Suppressant / Expectorant / Nasal Decongestant Tukol ® X-PECTO MIEL Cough & Cold Quiets Cough Thins & loosens Phlegm Clears Nasal Congestion NATURAL HONEY FLAFOR Ages / 12+ 4 FL OZ (118 ml) 2000006935 6 50066 00042 0 LOT no. Exp. Distributed by Genomma Lab USA Inc. Houston TX, 77027 BX-035 Rev. 02 Genomma Lab. ® rege Tokul X-PECTO 533-24 Box VER2 Tokul X-PECTO 533-24 Btl VER2"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use."],"purpose":["Purposes Cough Suppressant Expectorant Nasal Decongestant"],"questions":["Questions or comments? 1 877 99 GENOM (43666) Monday to Friday from 8 am to 6 pm, Central time."],"set_id":"b9d32964-5bd7-44b0-be98-827d5310ed4f","spl_product_data_elements":["Tukol X-Pecto Miel Multi Symptom Cold DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 GLYCERIN HONEY PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM HONEY"],"stop_use":["Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not get better within 7 days, or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition."],"version":"5","warnings":["Warnings Do not use 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."]}