{"active_ingredient":["Active ingredients section Active ingredients ( in each 2.5 ml) Dextrometorphan HBr, 7.5 mg Guaifenesin,150 mg Phenylephryne, 5 mg Active ingredients"],"ask_doctor_or_pharmacist":["Ask a doctor Ask a doctor before use if your child has *heart desease, high blood pressure, thryroid desease, diabetes* a cough with too much phlegm ( mucus)* a persistent or chronic cough as occurs with asthma or chronic bronchitis Ask a doctor or pharmacist before use if your child is taking any other nasal descongestant or stimulant, sedatives, tranquilizer, andndrugs used for depression, especially monoamine oxidase inhibitors (MAOIs)* When using this product do not use more than directed Stop use and ask a Doctor if * nervousness,dizziness or sleeplesness occur* sympton do not get better within 7 days or are accompanied by fever* cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent haedache . These could be signs of serious conditions. Ask a doctor"],"dosage_and_administration":["Directions and other information Directions* no take more than 6 doses in any 24 hours period * use enclosed dosing cup* keep dosage cup for use with this product* ml= mililiter Children under 4 years ----Consult a doctor children 4 to under 6 years------1.25 ml every 4 hours children 6 to under 12 years-----2.5 ml every 4 hours children 12 yeras and over -------5 ml every 4 hours Other information store at room temperature 15 - 30 0c* close cap tightly* save carton for complete drug facts Directions"],"dosage_forms_and_strengths":["Drug Facts Active Ingredients ( in each 2.5 ml) Purposes Dextrometorphan HBr, 7.5 mg ----------------------Cough suppresant Guafenesin, 150 mg -----------------------------------Expectorant Phenylepryne HCL, 5 mg -----------------------------Nasal Decongestant drug"],"effective_time":"20250917","id":"3f025ef6-79e8-e833-e063-6294a90ab501","inactive_ingredient":["Inactive Ingredients Inactive Ingredients Citric Acid, Flavor, Glycerin, Hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose"],"indications_and_usage":["Indication and Usage section Indication and Usage section no take more than 6 doses in any 24 hours period use enclosed dosing cup* keep dosage cup for use with this product* ml= mililiter Children under 4 years ----Consult a doctor children 4 to under 6 years------1.25 ml every 4 hours children 6 to under 12 years-----2.5 ml every 4 hours children 12 yeras and over -------5 ml every 4 hours indication an user"],"keep_out_of_reach_of_children":["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 inmediatly Keep out"],"openfda":{"application_number":["M012"],"brand_name":["Giltuss Childrens Cough and Cold"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Dextrum Laboratories Inc."],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["65852-011-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["65852-011"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1251031"],"spl_id":["3f025ef6-79e8-e833-e063-6294a90ab501"],"spl_set_id":["3f025ef6-79e7-e833-e063-6294a90ab501"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","PHENYLEPHRINE HYDROCHLORIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","04JA59TNSJ","495W7451VQ"]},"package_label_principal_display_panel":["Principal panel Childrens 4-12 Cough & Cold Alcohol free Sugar free Dye free Non -Drowsy Cherry Flavor Principal panel"],"pediatric_use":["Use section Uses * temporary 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 your child get to sleep* helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes*temporary relieves nasal congestion due to a cold*stuffy nose uses"],"pregnancy_or_breast_feeding":["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 Poisson Control Center inmediatly If pregnant"],"purpose":["Purpose sectiion Purpose sectiion Cough Suppressant Expectorant Nasal descongestant purpose"],"questions":["Questions section Call 1-787-848-9114, Monday-Friday 9AM-5PM EST Call your doctor for medical advice in the event of side efects Questions"],"set_id":"3f025ef6-79e7-e833-e063-6294a90ab501","spl_product_data_elements":["Giltuss Childrens Cough and Cold Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE METHYLPARABEN PROPYLENE GLYCOL WATER SUCRALOSE GUAIFENESIN GUAIFENESIN GLYCERIN PROPYLPARABEN SORBITOL SOLUTION CITRIC ACID HYDROXYETHYL CELLULOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED"],"version":"1","warnings":["Warnings Donot use if your child is now taking a prescription monoamine oxidase inhibitor (MAOI) ( certain drugs for deppresion, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your's child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this oroduct. warnings"]}