{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "PRESGEN PEDIATRIC GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE CITRUS ORANGE" ], "spl_unclassified_section": [ "Drug Facts", "Compare to Tussi-Pres ® Pediatric Dextromethorphan HBr COUGH SUPPRESSANT Guaifenesin EXPECTORANT Phenylephrine HCl NASAL DECONGESTANT SUGAR AND ALCOHOL FREE SACCHARIN AND SORBITOL FREE DYE FREE ORANGE FLAVOR KramerNovis Pharmaceuticals within reach of patients Manufactured in USA with imported ingredients for Kramer Novis San Juan, PR 00917 www.kramernovis.com" ], "active_ingredient": [ "Active ingredients ( in each 5 mL, 1 teaspoon ) Dextromethorphan HBr, 5 mg Guaifenesin, 75 mg Phenylephrine HCl, 2.5 mg" ], "purpose": [ "Purposes Cough Suppressant Expectorant Nasal Decongestant" ], "indications_and_usage": [ "Uses • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation" ], "warnings": [ "Warnings Do not use • in a child under 2 years of age • 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 a MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema. When using this product, do not exceed recommended dosage. 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, come back, or is accompanied by fever, rash, or persistent headache. 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 accidental overdose, get medical help or contact a Poison Control Center right away." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "Directions • do not take more than 6 doses in any 24-hour period. • mL = milliliter age dose Adults and Children 12 years of age and over 4 teaspoons (20 mL) every 4 hours Children 6 to under 12 years of age 2 teaspoons (10 mL) every 4 hours Children 2 to under 6 years of age 1 teaspoon (5 mL) every 4 hours Children under 2 years of age do not use" ], "dosage_and_administration_table": [ "
age dose
Adults and Children 12 years of age and over 4 teaspoons (20 mL) every 4 hours
Children 6 to under 12 years of age 2 teaspoons (10 mL) every 4 hours
Children 2 to under 6 years of age 1 teaspoon (5 mL) every 4 hours
Children under 2 years of age do not use
" ], "storage_and_handling": [ "Other information • Tamper evident feature: Do not use if security seal is torn, broken or missing. • Store at controlled room temperature 15-30°C (59-86°F). • Avoid excessive heat and humidity." ], "inactive_ingredient": [ "Inactive ingredients citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose." ], "questions": [ "Questions or comments? Call weekdays from 8AM to 4 PM AST at 1.787.767.2072" ], "package_label_principal_display_panel": [ "Packaging PRESGEN PEDIATRIC" ], "set_id": "12fb91e5-6059-4b3a-a2de-762aa51a25b7", "id": "6fa9d05a-47dd-4ede-b77b-ada155683617", "effective_time": "20251112", "version": "6", "openfda": { "application_number": [ "M012" ], "brand_name": [ "PRESGEN PEDIATRIC" ], "generic_name": [ "GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE" ], "manufacturer_name": [ "KRAMER NOVIS" ], "product_ndc": [ "52083-653" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DEXTROMETHORPHAN HYDROBROMIDE", "GUAIFENESIN", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1119541" ], "spl_id": [ "6fa9d05a-47dd-4ede-b77b-ada155683617" ], "spl_set_id": [ "12fb91e5-6059-4b3a-a2de-762aa51a25b7" ], "package_ndc": [ "52083-653-16" ], "is_original_packager": [ true ], "nui": [ "N0000193956", "N0000008867", "N0000009560" ], "pharm_class_epc": [ "Expectorant [EPC]" ], "pharm_class_pe": [ "Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]" ], "unii": [ "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ" ] } } ] }