{"active_ingredient":["Active ingredients (in each 10 mL) Dextromethorphan HBr, 20 mg Guaifenesin, 200 mg"],"ask_doctor":["Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough such as occurs with smoking, chronic bronchitis, or emphysema"],"do_not_use":["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."],"dosage_and_administration":["Directions do not exceed recommended dosage do not take more than 6 doses in any 24 hour period keep dosing cup for use with this product mL = milliliters adults and children 12 years & over 10 mL every 4 hours children 6 to under 12 years of age 5 mL every 4 hours children 2 to under 6 years of age 2.5 mL every 4 hours children under 2 years of age Consult a doctor"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>adults and children 12 years &amp; over</td><td>10 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 2 to under 6 years of age</td><td>2.5 mL every 4 hours</td></tr><tr><td>children under 2 years of age</td><td>Consult a doctor</td></tr></tbody></table>"],"effective_time":"20251009","id":"40b834bf-79a9-e4d1-e063-6294a90aa17d","inactive_ingredient":["Inactive ingredients Citric acid, 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 as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediately."],"openfda":{"application_number":["M012"],"brand_name":["Giltuss HBP Cough and Chest Congestion"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Gil Pharmaceutical Corp"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["58552-132-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["58552-132"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["996520"],"spl_id":["40b834bf-79a9-e4d1-e063-6294a90aa17d"],"spl_set_id":["852ceea2-d6a1-6de2-e053-2a91aa0ad50d"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"]},"package_label_principal_display_panel":["MAXIMUM STRENGTH HBP GILTUSS ® COUGH & CHEST CONGESTION ANTITUSSIVE AND EXPECTORANT ALCOHOL FREE. NON-DROWSY RELIEVES COUGH AND COLD CHEST CONGESTION LIQUIFIES AND LOOSENS PHLEGM AND MUCUS RASPBERRY FLAVOR 4FL OZ (118 mL) 58552-132 CoughChest Congestion"],"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":"852ceea2-d6a1-6de2-e053-2a91aa0ad50d","spl_product_data_elements":["Giltuss HBP 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 if 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":"7","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. Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough such as occurs with smoking, chronic bronchitis, or emphysema When using this product do not use more than directed. Stop use and ask a doctor if 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediately."],"when_using":["When using this product do not use more than directed."]}