{"active_ingredient":["Active ingredients (in each 5 mL) Dextromethorphan HBr 5 mg Guaifenesin 100 mg"],"ask_doctor":["Ask a doctor before use if the child has ■ persistent or chronic cough such as occurs with asthma ■ cough that occurs with too much phlegm (mucus)"],"do_not_use":["Do not use in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product."],"dosage_and_administration":["Directions ■ do not take more than 6 doses in any 24-hour period ■ shake well before use ■ measure only with dosing cup provided ■ keep dosing cup with product ■ mL=milliliter Age Dose children 6 years to under 12 years 5 mL - 10 mL every 4 hours children 4 years to under 6 years 2.5 mL - 5 mL every 4 hours children under 4 years do not use"],"dosage_and_administration_table":["<table border=\"0\"><tbody><tr><td><content styleCode=\"bold\">Age</content></td><td><content styleCode=\"bold\">Dose</content></td></tr><tr><td>children 6 years to under 12 years</td><td><paragraph>5 mL - 10 mL every 4 hours</paragraph></td></tr><tr><td>children 4 years to under 6 years</td><td>2.5 mL - 5 mL every 4 hours</td></tr><tr><td>children under 4 years</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20260508","id":"5151740a-8271-7bb5-e063-6294a90ae387","inactive_ingredient":["Inactive ingredients citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum."],"indications_and_usage":["Uses ■ temporarily relieves cough as may occur with the common cold ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus."],"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."],"openfda":{"application_number":["M012"],"brand_name":["Dr. Simi Children s Cough"],"generic_name":["DEXTROMETHORPHAN HBR, GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Farmacias De Similares TX LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["85786-604-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["85786-604"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020138"],"spl_id":["5151740a-8271-7bb5-e063-6294a90ae387"],"spl_set_id":["5151740a-8270-7bb5-e063-6294a90ae387"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"],"upc":["0199961000386"]},"other_safety_information":["Other information ■ each 5 mL contains: sodium 3 mg ■ store at room temperature 15-30°C (59-86°F) ■ Do not refrigerate ■ TAMPER-EVIDENT FEATURE: Do not use if printed safety seal is torn, broken or missing."],"package_label_principal_display_panel":["Carton labeling Carton labeling"],"purpose":["Purposes Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant"],"purpose_table":["<table border=\"0\"><tbody><tr><td>Dextromethorphan HBr 5 mg</td><td>Cough suppressant</td></tr><tr><td><paragraph>Guaifenesin 100 mg</paragraph></td><td><paragraph>Expectorant</paragraph></td></tr></tbody></table>"],"questions":["Questions or comments? 855-280-1079"],"set_id":"5151740a-8270-7bb5-e063-6294a90ae387","spl_product_data_elements":["Dr. Simi Children s Cough Dextromethorphan HBr, Guaifenesin PROPYLENE GLYCOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN FD&C RED NO. 40 CITRIC ACID XANTHAN GUM GLYCERIN SODIUM BENZOATE FD&C BLUE NO. 1 WATER SORBITOL SOLUTION GUAIFENESIN GUAIFENESIN SUCRALOSE"],"spl_unclassified_section":["Drug Facts .","Principal Display Pane NDC: 85786-604-04 DR. SIMI Children’s Cough Dextromethorphan HBr 5 mg Cough Suppressant Guaifenesin 100 mg Expectorant Ages 4+ Years ■ Controls cough ■ Relieves chest congestion ■ Breaks up mucus Free of alcohol, parabens & high fructose corn syrup 4 fl oz (118 mL) Cherry Flavor Compare to the active ingredients in Children’s Mucinex® Cough* *This product is not manufactured or distributed by RB Health (USA), distributor of Children’s Mucinex® Cough. 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 ■ cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition."],"version":"1","warnings":["Warnings . Do not use in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has ■ persistent or chronic cough such as occurs with asthma ■ cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away."]}