{"active_ingredient":["Active ingredients (in each 1 mL) Dextromethorphan HBr, 5 mg Guaifenesin, 50 mg Phenylephrine HCl, 2.5 mg"],"dosage_and_administration":["Directions • do not use more than 6 doses in any 24-hour period • repeat every 4 hours • measure with the dosage device provided. Do not use with any other device • mL = milliliter • Children 2 to under 6 years of age: 1 mL • Children under 2 years of age: do not use."],"effective_time":"20251120","id":"dc1e71f8-2a20-4968-b4ad-00c19b3d0dec","inactive_ingredient":["Inactive ingredients citric acid, FD&C Red 40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, sucralose"],"indications_and_usage":["Uses • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive • temporarily relieves: • nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) • cough due to minor throat and bronchial irritation as may occur with the common cold"],"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":["Supress DX Pediatric Drops"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["KRAMER NOVIS"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["52083-055-01"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["52083-055"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1095503"],"spl_id":["dc1e71f8-2a20-4968-b4ad-00c19b3d0dec"],"spl_set_id":["ddb95436-7806-4086-af4d-18a6625b5c83"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","495W7451VQ","04JA59TNSJ"],"upc":["0352083055010"]},"package_label_principal_display_panel":["Packaging Supress DX Pediatric Drops"],"purpose":["Purposes Cough Suppressant Expectorant Nasal Decongestant"],"questions":["Questions or comments? 1-787-767-2072 You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST."],"recent_major_changes":["Directions: (The following changes were made) mL=milliliter Children under 2 years of age: do not use. Unclassified section (The following information has been included) • For relief of: + Cough + Chest Congestion/Mucus + Stuffy Nose"],"set_id":"ddb95436-7806-4086-af4d-18a6625b5c83","spl_product_data_elements":["Supress DX Pediatric Drops Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN METHYLPARABEN POTASSIUM SORBATE PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE SOUR CHERRY CHERRY RED"],"spl_unclassified_section":["Drug Facts","• Cough suppressant - Dextromethorphan HBr • Expectorant - Guaifenesin • Nasal Decongestant - Phenylephrine HCl PEDIATRIC DROPS 2 TO 6 YEARS For relief of: + Cough + Chest Congestion/Mucus + Stuffy Nose Sugar & Alcohol Free Cherry Flavor NET CONTENTS: 30 ML (1 Fl. Oz.) Kramer Novis Pharmaceuticals within reach of patients RETAIN CARTON FOR FULL PRESCRIBING INFORMATION Manufactured in USA with imported ingredients for Kramer Novis San Juan, PR 00917"],"storage_and_handling":["Other information • Tamper Evident Feature: Do not use if printed seal is torn, broken or missing • Store at controlled room temperature 15-30°C (59-86°F) • Avoid excessive heat and humidity."],"version":"8","warnings":["Warnings Do not use 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 • thyroid disease • high blood pressure • diabetes • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with asthma. When using this product, do not use more than directed. Stop use and ask a doctor if • your child gets nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."]}