{"active_ingredient":["Drug Facts Active ingredient (in each 10 mL) Purpose Dextromethorphan HBr. 30 mg .... Cough Suppresant"],"ask_doctor":["Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema"],"ask_doctor_or_pharmacist":[""],"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. When using this product do not use more than directed."],"dosage_and_administration":["Directions do not exceed recommended dosage do not take more than 4 doses in any 24-hour period use enclosed dosing cup ml= milliliter Adults and children over 12 years 10 mL every 8 hours Children under 6 years to under 12 years 5 mL every 8 hours Children 4 years to under 6 years 2.5 mL* every 8 hours Children under 4 years Do not use *use appropriate measuring syringe or measuring cup"],"dosage_and_administration_table":["<table border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"50%\"><tbody><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule\"><paragraph>Adults and children over 12 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule\"><paragraph>10 mL every 8 hours</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule\"><paragraph>Children under 6 years to under 12 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule\"><paragraph>5 mL every 8 hours</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule\"><paragraph>Children 4 years to under 6 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule\"><paragraph>2.5 mL* every 8 hours</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule\"><paragraph>Children under 4 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Botrule\"><paragraph>Do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20251009","id":"40b96169-c482-7688-e063-6294a90a154c","inactive_ingredient":["Inactive ingredients Acesulfame potassium, citric acid, flavor, glycerin, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin."],"indications_and_usage":["Uses ■ temporarily relieves: cough due to minor throat and bronchial irritation associated with a common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep"],"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 DM"],"generic_name":["DEXTROMETHORPHAN HBR"],"is_original_packager":[true],"manufacturer_name":["Gil Pharmaceutical Corp"],"package_ndc":["58552-150-04"],"product_ndc":["58552-150"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1090496"],"spl_id":["40b96169-c482-7688-e063-6294a90a154c"],"spl_set_id":["1a4fe686-3085-4543-bd6c-f20580b1df50"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["9D2RTI9KYH"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Giltuss DM High Blood Pressure - NDC 58552-150-04 - Bottle Label Giltuss DM High Blood Pressure - NDC 58552-150-04 - Carton Label image description image description"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":[""],"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. Label revised: 02/23 MANUFACTURED FOR GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00717-1565"],"set_id":"1a4fe686-3085-4543-bd6c-f20580b1df50","spl_product_data_elements":["Giltuss DM Dextromethorphan HBR ACESULFAME POTASSIUM CITRIC ACID MONOHYDRATE RASPBERRY GLYCERIN MENTHOL POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SODIUM BENZOATE SACCHARIN SODIUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN clear color"],"stop_use":["Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache as these could be signs of a serious condition."],"storage_and_handling":["Other information store at room temperature 15°-30°c (59°-86°F) close cap tightly SAVE CARTON FOR COMPLETE DRUG FACTS"],"version":"5","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. When using this product do not use more than directed. Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache as 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 overdose, get medical help or contact a Poison Control Center right away."],"when_using":[""]}