{ "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": [ "Tussi Pres guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE SOUR CHERRY CHERRY RED" ], "spl_unclassified_section": [ "Drug Facts", "Dextromethorphan HBr COUGH SUPPRESSANT Guaifenesin EXPECTORANT Phenylephrine HCl NASAL DECONGESTANT SUGAR ALCOHOL SACCHARIN FREE SORBITOL CHERRY FLAVOR Kramer Novis 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, 10 mg Guaifenesin, 200 mg Phenylephrine HCl, 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 • 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 a 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 • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • 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 • you get 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. 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. age dose Adults and Children 12 years of age and over 2 teaspoons (10 mL) every 4 hours Children 6 to under 12 years of age 1 teaspoon (5 mL) every 4 hours Children under 6 years of age do not use" ], "dosage_and_administration_table": [ "
age dose
Adults and Children 12 years of age and over 2 teaspoons (10 mL) every 4 hours
Children 6 to under 12 years of age1 teaspoon (5 mL) every 4 hours
Children under 6 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, FD&C Red 40, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose." ], "questions": [ "Questions or comments? Call weekdays from 8AM to 4PM AST at 1.787.767.2072" ], "package_label_principal_display_panel": [ "Packaging Tussi Pres" ], "set_id": "0d4ee530-2a5c-41a0-88bf-ac92d538661b", "id": "15192bad-05a9-4d18-9604-db4122f47aad", "effective_time": "20251112", "version": "5", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Tussi Pres" ], "generic_name": [ "GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE" ], "manufacturer_name": [ "Kramer Novis" ], "product_ndc": [ "52083-231" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DEXTROMETHORPHAN HYDROBROMIDE", "GUAIFENESIN", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1098647" ], "spl_id": [ "15192bad-05a9-4d18-9604-db4122f47aad" ], "spl_set_id": [ "0d4ee530-2a5c-41a0-88bf-ac92d538661b" ], "package_ndc": [ "52083-231-16", "52083-231-04", "52083-231-10" ], "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" ] } } ] }