{ "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": "2026-10-14", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Poly-Vent DM Dextromethorphan HBr, Guaifenesin and Pseudoephedrine HCl PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE FD&C YELLOW NO. 5 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN POLY214 Oblong" ], "spl_unclassified_section": [ "Drug Facts", "Other information Tamper evident: do not use if tamper evident seal is broken or missing. Store at 15°-30°C (59°-86°F). Poly Vent DM is a yellow, oblong, capsule shaped, scored tablet, debossed POLY 214 on one side and blank on the other.", "Questions? Comments? Call 1-800-882-1041. Manufactured for: Poly Pharmaceuticals Quitman, MS 39355 (800) 882-1041 Rev. 04/13" ], "active_ingredient": [ "Active ingredients Dextromethorphan HBr 20mg Guaifenesin 380mg Pseudoephedrine HCl 60mg" ], "purpose": [ "Purpose Cough Suppressant Expectorant Nasal Decongestant" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat and bronchial irritation associated with a cold alleviates cough to help you sleep non-narcotic cough suppressant for relief of cough helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive itchy, watery eyes nasal congestion runny nose sneezing itching of the nose and throat" ], "warnings": [ "Warnings Do not exceed recommended dosage. a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Ask a doctor or pharmacist before use if you are now 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 an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have : a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occur 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." ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are now 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 an MAOI, ask a doctor or pharmacist before taking this product." ], "ask_doctor": [ "Ask a doctor before use if you have : a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland" ], "stop_use": [ "Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occur" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast feeding, ask a health professional before use." ], "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." ], "dosage_and_administration": [ "Directions Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor. Children age 6 to under 12 years of age: ½ tablet every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor. Children 2 to under 6 years of age: Consult a doctor." ], "dosage_and_administration_table": [ "
Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor.
Children age 6 to under 12 years of age:½ tablet every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor.
Children 2 to under 6 years of age:Consult a doctor.
" ], "inactive_ingredient": [ "Inactive ingredients FD&C Yellow #5, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50991-214-01 Poly-Vent DM Tablets Cough Suppressant Expectorant ● Nasal Decongestant 100 tablets front back" ], "set_id": "739329ae-0b62-4eab-a07d-867b5d3d61e0", "id": "46518b53-5ca9-c68b-e063-6394a90a4150", "effective_time": "20251219", "version": "12", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Poly-Vent DM" ], "generic_name": [ "DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL" ], "manufacturer_name": [ "Poly Pharmaceuticals, Inc." ], "product_ndc": [ "50991-214" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PSEUDOEPHEDRINE HYDROCHLORIDE", "GUAIFENESIN", "DEXTROMETHORPHAN HYDROBROMIDE" ], "rxcui": [ "1427998" ], "spl_id": [ "46518b53-5ca9-c68b-e063-6394a90a4150" ], "spl_set_id": [ "739329ae-0b62-4eab-a07d-867b5d3d61e0" ], "package_ndc": [ "50991-214-02", "50991-214-01" ], "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": [ "6V9V2RYJ8N", "495W7451VQ", "9D2RTI9KYH" ] } } ] }