{"active_ingredient":["Active ingredients (in each 2.5 mL) Dextromethorphan HBr 7.5 mg Guaifenesin 150 mg Phenylephrine HCI 5 mg"],"ask_doctor":["Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as occurs with asthma or chronic bronchitis"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the child is taking any other oral nasal decongestant or stimulant taking sedatives, tranquilizers"],"do_not_use":["Do not use to sedate a child or make a child sleepy 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 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 children under 2 years Consult a doctor children 2 to under 6 years of age 1.25 mL every 4 hours children 6 to 12 years of age 2.5 mL every 4 hours children 12 years and over 5 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>1.25 mL every 4 hours</td></tr><tr><td>children 6 to 12 years of age</td><td>2.5 mL every 4 hours</td></tr><tr><td>children 12 years and over</td><td>5 mL every 4 hours</td></tr></tbody></table>"],"effective_time":"20251009","id":"40b823a5-5359-e635-e063-6394a90a4283","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 associated with the common cold or inhaled irritants the intensity of coughing the impulse to cough helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes stuffy nose"],"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 Cold"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Gil Pharmaceutical Corp"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["58552-131-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["58552-131"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1251031"],"spl_id":["40b823a5-5359-e635-e063-6394a90a4283"],"spl_set_id":["852b77ae-a5ac-3ead-e053-2a91aa0a54bd"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["Children's GILTUSS ® COUGH & COLD ANTITUSSIVE, EXPECTORANT, NASAL DECONGESTANT Alcohol Free. Sugar Free. Dye Free. COUGH AND COLD CHEST CONGESTION STUFFY NOSE NASAL CONGESTION LOOSEN PHLEGM AND MUCUS SINUS PRESSURE CHERRY FLAVOR 4 FL OZ (118 mL) 58552-131 Child Cough Cold Liq"],"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":"852b77ae-a5ac-3ead-e053-2a91aa0a54bd","spl_product_data_elements":["Giltuss Childrens 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 sleepless occurs symptoms do not get better within 7 days or are accompanied by fever cough lasts 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 to sedate a child or make a child sleepy 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 heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as occurs with asthma or chronic bronchitis Ask a doctor or pharmacist before use if the child is taking any other oral nasal decongestant or stimulant taking sedatives, tranquilizers Stop use and ask a doctor if nervousness, dizziness, or sleepless occurs symptoms do not get better within 7 days or are accompanied by fever cough lasts 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 overdose, get medical help or contact a Poison Control Center right away."]}