{"active_ingredient":["Active Ingredients Active Ingredients ________________Purposes (in each 10mL= 2 teaspoonfull) Acetaminophen 250mg ........................Pain reliever/fever reducer Dextromethorphan HBr 13.33mg..........Cough suppressant Guaifesin USP 200mg...........................Expectorant Phenylephrine HCl 5mg.........................Nasal descongestant Purpose Active ingredients (in each 10 mL=2 teaspoonful) Purposes Acetaminophen 250 mg Pain reliever/fever reducer Dextromethorphan HBr 13.33mg Cough suppressant Guaifenesin USP 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant"],"active_ingredient_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredients (in each 10 mL=2 teaspoonful)</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purposes</content></content></td></tr><tr><td>Acetaminophen 250 mg</td><td>Pain reliever/fever reducer</td></tr><tr><td>Dextromethorphan HBr 13.33mg</td><td>Cough suppressant</td></tr><tr><td>Guaifenesin USP 200 mg</td><td>Expectorant</td></tr><tr><td>Phenylephrine HCl 5 mg</td><td>Nasal decongestant</td></tr></tbody></table>"],"ask_doctor":["Ask a doctor before use if you have liver disease heart disease diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sodium restricted diet"],"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 for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkison´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 do not take more than directed (see Overdose warning) do not take more than 6 doses in any 24 hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL=milliliter tsp=teaspoonful Children 6 to under 12 years of age 10mL or 2 tsp in dosing cup provided every 4 hours Children under 6 years of age do not use"],"effective_time":"20240926","id":"2309620a-ccbd-41e9-e063-6394a90a9520","inactive_ingredient":["Inactive ingredients Aloe vera, citric acid, disodium EDTA, FD&C red no 40, hydroxyethyl cellulose, natural & artificial strawberry flavor, propylene glycol USP, purified water, sodium benzoate, sorbitol 70% USP, sucralose."],"indications_and_usage":["Uses Uses temporarily relieves these common cold and flu symptoms: sinus congestion and pressure minor aches and pains nasal congestion cough due to minor throat and bronchial irritation sore throat headache temporarily reduces fever temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive"],"keep_out_of_reach_of_children":["Keep out of reach of children ."],"openfda":{"application_number":["M012"],"brand_name":["Tesalon Children"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["OPMX LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["69729-786-06"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["69729-786"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1790651"],"spl_id":["2309620a-ccbd-41e9-e063-6394a90a9520"],"spl_set_id":["2309620a-ccbc-41e9-e063-6394a90a9520"],"substance_name":["GUAIFENESIN","DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE","ACETAMINOPHEN"],"unii":["495W7451VQ","9D2RTI9KYH","04JA59TNSJ","362O9ITL9D"]},"package_label_principal_display_panel":["Principal Display Panel NDC 69729-786-06 Tesalon® Infantil Gripe, Resfriado & Garganta Irritada Máxima Potencia Alivia Fiebre y Dolor de Cabeza (Acetaminophen) Control de la Tos (Dextromethorphan HBr) Adelgaza y Expulsa las Flemas (Guaifenesin) Alivia la Congestión Nasal (Phenylephrine HCl) Alivio hasta por 8 horas Caja con frasco de 6FL OZ (177mL) y vasito dosificador NDC 69729-786-06 Tesalon® Children Cold, Flu & Sore Throat Maximum Strenght Relieves Headache & Fever (Acetaminophen) Controls Cough (Dextromethorphan HBr) Thins & Loosens Mucus (Guaifenesin) Relieves Nasal Congestion (Phenylephrine HCl) Relief up to 8 hours Box with bottle of 6 FL OZ (177mL) and measuring cup Tesalon Children 6 fl oz"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask health professional before use"],"purpose":["Purpose Active ingredients (in each 10 mL=2 teaspoonful) Purposes Acetaminophen 250 mg Pain reliever/fever reducer Dextromethorphan HBr 13.33mg Cough suppressant Guaifenesin USP 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant"],"purpose_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredients (in each 10 mL=2 teaspoonful)</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purposes</content></content></td></tr><tr><td>Acetaminophen 250 mg</td><td>Pain reliever/fever reducer</td></tr><tr><td>Dextromethorphan HBr 13.33mg</td><td>Cough suppressant</td></tr><tr><td>Guaifenesin USP 200 mg</td><td>Expectorant</td></tr><tr><td>Phenylephrine HCl 5 mg</td><td>Nasal decongestant</td></tr></tbody></table>"],"questions":["Questions or comments? Call 619-600-5632 MON to FRI, 9 a.m. to 6 p.m. PTZ"],"set_id":"2309620a-ccbc-41e9-e063-6394a90a9520","spl_product_data_elements":["Tesalon Children Acetaminophen, Dextromethorphan HBr, Guafeisin USP, Phenylephrine HCl SORBITOL SOLUTION 70% GUAIFENESIN GUAIFENESIN SODIUM BENZOATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROXYETHYL CELLULOSE, UNSPECIFIED ANHYDROUS CITRIC ACID FD&C RED NO. 40 WATER EDETATE DISODIUM PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ALOE ACETAMINOPHEN ACETAMINOPHEN PROPYLENE GLYCOL SUCRALOSE"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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 fever, rash, or headache that lasts. These could be signs of a serious condition."],"storage_and_handling":["Other information each 10 mL contains: sodium 10mg store between 20-25°C (68-77°F) do not refrigerate keep carton for complete Drug Facts"],"version":"1","warnings":["Warnings Liver Warning This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 doses in 24 hours, which is the maximum daily amount 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 for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkison´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 diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sodium restricted diet When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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 fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding ask health professional before use Keep out of reach of children . Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms."],"when_using":["When using this product do not exceed recommended dose (see overdose warning)"]}