{"active_ingredient":["Active ingredients (in each tablet) Doxylamine Succinate 10.5mg","Active ingredients (in each tablet) Phenylephrine HCl 10 mg"],"ask_doctor":["Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma","Ask a doctor before use if you are taking sedatives or tranquilizers."],"do_not_use":["Do not use this product 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 Do not exceed recommended dosage. Adults and children 12 years of age and over 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours. Children 6 to 12 years of age: 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours. Children 6 years of age and younger: Consult a physician."],"dosage_and_administration_table":["<table><col width=\"295\"/><col width=\"295\"/><tbody><tr><td> Adults and children 12 years of age and over</td><td> 1 tablet every 4 hours, not to  exceed 6 tablets in 24 hours. </td></tr><tr><td> Children 6 to 12 years of age: </td><td> 1/2 tablet every 4 hours, not to  exceed 3 tablets in 24 hours. </td></tr><tr><td> Children 6 years  of age and younger: </td><td> Consult a physician.</td></tr></tbody></table>"],"effective_time":"20240709","id":"1cda46d8-607e-048a-e063-6394a90a6d65","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: nasal congestion reduces swelling of nasal passages runny nose sneezing itching of nose or 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 Hist Forte"],"generic_name":["DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Poly Pharmaceuticals, Inc."],"package_ndc":["50991-626-02","50991-626-01"],"product_ndc":["50991-626"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2172491"],"spl_id":["1cda46d8-607e-048a-e063-6394a90a6d65"],"spl_set_id":["8aa0015b-8fc1-7951-e053-2a95a90a8e72"],"substance_name":["DOXYLAMINE SUCCINATE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["V9BI9B5YI2","04JA59TNSJ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 50991-626-01 POLY HIST FORTE ® TABLETS Nasal Decongestant • Antihistamine NEW FORMULA Each tablet contains: Doxylamine Succinate . . . 10.5 mg Phenylephrine HCl . . . . . . 10 mg 100 Tablets back label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine","Purpose Nasal Decongestant"],"set_id":"8aa0015b-8fc1-7951-e053-2a95a90a8e72","spl_product_data_elements":["Poly Hist Forte Doxylamine Succinate and Phenylephrine Hydrochloride FD&C BLUE NO. 2 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Poly;216"],"spl_unclassified_section":["Drug Facts","Do not exceed recommended dosage.","Other information Store at controlled room temperature between 15°-30°C (59°-86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Poly Hist Forte Tablets are blue, caplet-shaped, scored tablets, debossed \"Poly\" bisect \"216\" on one side and plain on the other.","Questions? Comments? Call 1-800-882-1041 Manufactured for: Poly Pharmaceuticals, Inc. Huntsville, AL Rev. 4/16"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever"],"version":"6","warnings":["Warnings"],"when_using":["When using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery"]}