{"active_ingredient":["Active ingredients (in each 5 mL) Dextromethorphan HBr, 10 mg Guaifenesin, 100 mg"],"ask_doctor":["Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as occurs with asthma"],"do_not_use":["Do not use if your child is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."],"dosage_and_administration":["Directions do not take more than 6 doses in any 24 hour period use enclosed dosing cup keep dosing cup for use with this product mL = milliliters children under 2 years Consult a doctor children 2 to under 6 years of age 2.5 mL every 4 hours children 6 to under 12 years of age 5 mL every 4 hours children 12 years and over 10 mL every 4 hours"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>children under 2 years</td><td>Consult a doctor</td></tr><tr><td>children 2 to under 6 years of age</td><td>2.5 mL every 4 hours</td></tr><tr><td>children 6 to under 12 years of age</td><td>5 mL every 4 hours</td></tr><tr><td>children 12 years and over</td><td>10 mL every 4 hours</td></tr></tbody></table>"],"effective_time":"20251009","id":"40b83871-7eac-3d44-e063-6394a90a2b29","inactive_ingredient":["Inactive ingredients Citric acid, flavor, D&C red #33, flavor, methylparaben, propylene glycol, propylparaben, purified water, and sucrose"],"indications_and_usage":["Uses temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes"],"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":["Giltuss Childrens Cough and Chest Congestion"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Gil Pharmaceutical Corp"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["58552-133-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["58552-133"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["996520"],"spl_id":["40b83871-7eac-3d44-e063-6394a90a2b29"],"spl_set_id":["852d5f01-9289-5515-e053-2a91aa0acf32"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"]},"package_label_principal_display_panel":["Children's GILTUSS ® COUGH & CHEST CONGESTION ANTITUSSIVE AND EXPECTORANT Non-Drowsy. Alcohol Free COUGH AND COLD CHEST CONGESTION LIQUIFIES AND LOOSENS PHLEGM AND MUCUS RASPBERRY FLAVOR 4FL OZ (118 mL) 58552-133 Child CoughChestCongestion"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Cough Suppressant Expectorant"],"questions":["Questions or comments? Call 1-787-848-9114 , Monday - Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects."],"set_id":"852d5f01-9289-5515-e053-2a91aa0acf32","spl_product_data_elements":["Giltuss Childrens Cough and Chest Congestion Dextromethorphan hydrobromide, Guaifenesin D&C RED NO. 33 WATER SUCROSE ANHYDROUS CITRIC ACID PROPYLPARABEN PROPYLENE GLYCOL METHYLPARABEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN"],"spl_unclassified_section":["Drug Facts","Other information store at room temperature 15°- 30°C (59° - 86°F) close cap tightly SAVE CARTON FOR COMPLETE DRUG FACTS","Tamper evident: do not use if safety seal is broken or missing MANUFACTURED FOR GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00717-1565"],"stop_use":["Stop use and ask a doctor or pharmacist if the child has symptoms do not get better within 7 days or are accompanied by fever cough comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition."],"version":"6","warnings":["Warnings Do not use if your child is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as occurs with asthma Stop use and ask a doctor or pharmacist if the child has symptoms do not get better within 7 days or are accompanied by fever cough comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. When using this product do not use more than directed. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product do not use more than directed."]}