{"active_ingredient":["Active ingredients (in each 5 mL) Dextromethorphan HBr, 15 mg Guaifenesin, 300 mg Phenylephrine HCI, 10 mg"],"ask_doctor":["Ask a doctor before use if you have heart disease, high blood pressure, thyroid disease, or diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor a cough with too much phlegm (mucus) a persistent or chronic cough such as occurs with smoking, chronic bronchitis, or emphysema"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant, sedatives, tranquilizers, and drugs for depression, especially monoamine oxidase inhibitors (MAOIs)."],"do_not_use":["Do not use if you are 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 5 mL every 4 hours children 6 to under 12 years of age 2.5 mL every 4 hours children 2 to 6 years of age 1.25 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>5 mL every 4 hours</td></tr><tr><td>children 6 to under 12 years of age</td><td>2.5 mL every 4 hours</td></tr><tr><td>children 2 to 6 years of age</td><td>1.25 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":"40b83027-94f0-8f48-e063-6294a90ad555","inactive_ingredient":["Inactive ingredients Citric acid, flavor, glycerin, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose."],"indications_and_usage":["Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to a cold"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accident overdose, get medical or professional help or contact a Poison Control Center immediately."],"openfda":{"application_number":["M012"],"brand_name":["Giltuss Cough and Cold"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Gil Pharmaceutical Corp"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["58552-130-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["58552-130"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1251031"],"spl_id":["40b83027-94f0-8f48-e063-6294a90ad555"],"spl_set_id":["8503c956-42a5-7684-e053-2991aa0adb27"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["MAXIMUM STRENGTH GILTUSS ® COUGH & COLD ALCOHOL FREE. SUGAR FREE. DYE FREE RELIEVES COUGH AND COLD CHEST CONGESTION LOOSENS PHLEGM AND MUCUS STUFFY NOSE NASAL CONGESTION SINUS PRESSURE 4 FL OZ (118 mL) 58552-130"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Cough Suppressant Expectorant Nasal Decongestant"],"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":"8503c956-42a5-7684-e053-2991aa0adb27","spl_product_data_elements":["Giltuss Cough and Cold Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride WATER POLYETHYLENE GLYCOL, UNSPECIFIED SORBITOL SUCRALOSE ANHYDROUS CITRIC ACID PROPYLPARABEN PROPYLENE GLYCOL METHYLPARABEN HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) GLYCERIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"],"spl_unclassified_section":["Drug Facts","Other information store at room temperature 15°- 30°C (59° - 86°F) close cap tightlly 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 nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or are accompanied by fever cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistant headache These can be signs of a serious condition."],"version":"6","warnings":["Warnings Do not use if you are 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 heart disease, high blood pressure, thyroid disease, or diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor a cough with too much phlegm (mucus) a persistent or chronic cough such as occurs with smoking, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant, sedatives, tranquilizers, and drugs for depression, especially monoamine oxidase inhibitors (MAOIs). Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or are accompanied by fever cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistant headache These can 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 accident overdose, get medical or professional help or contact a Poison Control Center immediately."]}