{"active_ingredient":["Active ingredients (in each tablet) Guaifenesin 380mg Pseudoephedrine HCl 60 mg"],"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 if cough is accompanied by excessive phlegm heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland"],"do_not_use":["Do not 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."],"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":["<table><col width=\"245\"/><col width=\"245\"/><tbody><tr><td styleCode=\"Toprule Rrule \">Adults and children 12 years of age and over:</td><td styleCode=\"Toprule Lrule \">1 tablet every 4 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor.</td></tr><tr><td styleCode=\"Toprule Rrule \">Children age 6 to under 12 years of age:</td><td styleCode=\"Toprule Lrule \">&#xBD; tablet every 4 hours, not to exceed 2 tablets in 24 hours, or as directed by a doctor. </td></tr><tr><td styleCode=\"Toprule Rrule \">Children 2 to under 6 years of age:</td><td styleCode=\"Toprule Lrule \">Consult a doctor.</td></tr></tbody></table>"],"effective_time":"20241109","id":"26838be8-5a59-bb4d-e063-6394a90affe9","inactive_ingredient":["Inactive ingredients FD&C Blue #2, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate."],"indications_and_usage":["Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: helps loosen phlegm and thin bronchial secretions to make coughs more productive nasal congestion runny nose sneezing itching of the nose and throat itchy, watery eyes"],"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":["Poly-Vent IR"],"generic_name":["GUAIFENESIN AND PSEUDOEPHEDRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Poly Pharmaceuticals, Inc."],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["50991-212-01","50991-212-02"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["50991-212"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1426579"],"spl_id":["26838be8-5a59-bb4d-e063-6394a90affe9"],"spl_set_id":["ce0d8c45-446a-4df4-a36b-5000ba69d30d"],"substance_name":["GUAIFENESIN","PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["495W7451VQ","6V9V2RYJ8N"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 50991-212-01 Poly-Vent IR Tablets Expectorant ● Nasal Decongestant 100 tablets front back"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, ask a health professional before use."],"purpose":["Purpose Expectorant Nasal Decongestant"],"set_id":"ce0d8c45-446a-4df4-a36b-5000ba69d30d","spl_product_data_elements":["Poly-Vent IR Guaifenesin and Pseudoephedrine HCl FD&C BLUE NO. 2 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE POLY212"],"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 IR Tablets are a blue, oval, scored tablet debossed POLY 212 on one side, plain on the other.","Questions? Comments? Call 1-800-882-1041. Manufactured for: Poly Pharmaceuticals Quitman, MS 39355 (800) 882-1041 Rev. 04/13"],"stop_use":["Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occur"],"version":"9","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. Do not 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 if cough is accompanied by excessive phlegm 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."]}