{"active_ingredient":["Active ingredients (in each 5 mL tsp.) Purpose Acetaminophen 250 mg Analgesic and Antipyretic Dextromethorphan HBr 10 mg Cough Suppressant Chlorpheniramine Maleate 4 mg Antihistamine Phenylephrine HCl 10 mg Nasal Decongestant"],"active_ingredient_table":["<table width=\"65%\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients (in each 5 mL tsp.)</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Acetaminophen 250 mg</td><td>Analgesic and Antipyretic</td></tr><tr><td>Dextromethorphan HBr 10 mg</td><td>Cough Suppressant</td></tr><tr><td>Chlorpheniramine Maleate 4 mg</td><td>Antihistamine</td></tr><tr><td>Phenylephrine HCl 10 mg</td><td>Nasal Decongestant</td></tr></tbody></table>"],"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 If you are not 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 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 allergic to acetaminophen or any of the inactive ingredients in the product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor if you are taking sedatives or tranquilizers, without first consulting your doctor."],"dosage_and_administration":["Directions Do not exceed more than 6 doses for children and adults in a 24 - hour period. Adults and Children 12 years of age and over 1 teaspoon (5 mL), every 4 hours Children 6 to under 12 years of age 1/2 teaspoon (2.5 mL), every 4 hours Children under 6 years of age Ask a doctor"],"dosage_and_administration_table":["<table width=\"50%\"><col width=\"50%\" align=\"left\" valign=\"middle\"/><col width=\"50%\" align=\"left\" valign=\"middle\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">Adults and Children 12 years of age and over</td><td styleCode=\"Rrule\">1 teaspoon (5 mL), every 4 hours</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">Children 6 to under 12 years of age</td><td styleCode=\"Rrule\">1/2 teaspoon (2.5 mL), every 4 hours</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">Children under 6 years of age</td><td styleCode=\"Rrule\">Ask a doctor</td></tr></tbody></table>"],"effective_time":"20210701","id":"c6132271-8ef9-4f4c-e053-2995a90a42a3","inactive_ingredient":["Inactive ingredients Banana Flavor, cherry flavor, FD&C yellow #5, glycerin, polyethylene glycol 400, methyl paraben (as preservative), natrasol, propyl paraben (as preservative), purified water, sucralose and titanium dioxide."],"indications_and_usage":["Uses Temporarily relieves runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever nasal congestion due to the common cold Calms the cough control center and relieves coughing minor aches and pains associated with the common cold temporarily reduces fever."],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton NDC 49523-505-04 Baczol ® COLD MEDICINE Acetaminophen • Analgesic and Antipyretic Dextromethorphan HBr • Cough Suppressant Chlorpheniramine Maleate • Antihistamine Phenylephrine HCl • Nasal Decongestant Fruit Flavor Sugar FREE Alcohol FREE 4 fl. oz. Laboratorios López Manufactured For: Laboratorios López, S.A. de C.V. Boulevard del Ejército Nacional, Km. 5 1/2, Soyapango, San Salvador, El Salvador, C.A. PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each 5 mL tsp.) Purpose Acetaminophen 250 mg Analgesic and Antipyretic Dextromethorphan HBr 10 mg Cough Suppressant Chlorpheniramine Maleate 4 mg Antihistamine Phenylephrine HCl 10 mg Nasal Decongestant"],"purpose_table":["<table width=\"65%\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients (in each 5 mL tsp.)</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Acetaminophen 250 mg</td><td>Analgesic and Antipyretic</td></tr><tr><td>Dextromethorphan HBr 10 mg</td><td>Cough Suppressant</td></tr><tr><td>Chlorpheniramine Maleate 4 mg</td><td>Antihistamine</td></tr><tr><td>Phenylephrine HCl 10 mg</td><td>Nasal Decongestant</td></tr></tbody></table>"],"questions":["Preguntas o comentarios / Questions or comments? 1-888-795-4540"],"set_id":"d46090ad-63c5-4161-a4ea-5bcd98ff25ce","spl_product_data_elements":["Baczol Cold Medicine ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, and CHLORPHENIRAMINE MALEATE GLYCERIN POLYETHYLENE GLYCOL 400 METHYLPARABEN HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) PROPYLPARABEN WATER SUCRALOSE TITANIUM DIOXIDE FD&C YELLOW NO. 5 ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE"],"spl_unclassified_section":["Drug Facts","Distributed in the USA by: PLAZA IZALCO WHOLESALE 417, Clifford Avenue, Alexandria VA, 22305"],"stop_use":["Stop Use and ask a Doctor if you have liver disease pain, cough or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur you have a breathing problem such as emphysema or chronic bronchitis you have glaucoma or difficulty in urination due to enlargement of the prostate gland you have shortness of breath, asthma, heart disease, high blood pressure, thyroid disease, diabetes"],"storage_and_handling":["Other information Store at room temperature 15°-30°C (59°-86°F). Tamper evident Do not use if there is evidence of tampering."],"version":"2","warnings":["Warnings Liver warning This products contains acetaminophen Severe liver damage may occur if adult takes more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 6 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician. Stop Use and ask a Doctor if you have liver disease pain, cough or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur you have a breathing problem such as emphysema or chronic bronchitis you have glaucoma or difficulty in urination due to enlargement of the prostate gland you have shortness of breath, asthma, heart disease, high blood pressure, thyroid disease, diabetes Ask a Doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. May cause excitability especially in children. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving motor vehicle or operating machinery. Precaution this product contains FD&C Yellow #5 (Tartrazine) as color additive. Do Not Use If you are not 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 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 allergic to acetaminophen or any of the inactive ingredients in the product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor if you are taking sedatives or tranquilizers, without first consulting your doctor. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose Warning taking more than recommended dose (overdose) may cause liver damage. In case of accidental overdose, contact a physician or Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"when_using":["When using this product, do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. May cause excitability especially in children. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving motor vehicle or operating machinery."]}