{ "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": 20 } }, "results": [ { "spl_product_data_elements": [ "ALA-HIST IR Dexbrompheniramine Maleate CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE DEXBROMPHENIRAMINE MALEATE DEXBROMPHENIRAMINE dark green Poly;783" ], "active_ingredient": [ "Drug Facts Active ingredients (in each tablet) Dexbrompheniramine Maleate 2 mg Purpose Antihistamine" ], "purpose": [ "Purpose Antihistamine" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes" ], "warnings": [ "Warnings Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery 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 taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use." ], "when_using": [ "When using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use." ], "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 to 6 hours, not to exceed 6 tablets in 24 hours. Children 6 to under 12 years of age: 1/2 tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours. Children 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 to 6 hours, not to exceed 6 tablets in 24 hours.
Children 6 to under 12 years of age: 1/2 tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours.
Children under 6 years of age: Consult a doctor.
" ], "storage_and_handling": [ "Other information Store at 15° - 30°C (59° - 86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Contains color additives including FD&C Yellow No. 5 (tartrazine). Ala-Hist IR Tablets are dark green caplet shaped, scored tablets, debossed \"Poly\" bisect \"783\" on one side and plain on the other." ], "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #1 aluminum lake, FD&C Yellow #5 aluminum lake, magnesium stearate, and silicified microcrystalline cellulose." ], "questions": [ "Questions? Call 1-800-882-1041 Manufactured for: Poly Pharmaceuticals Quitman, MS 39355 Rev. 02/12" ], "package_label_principal_display_panel": [ "Product Packaging The packaging below represents the labeling currently used. Principal display panel and side panel for 60 tablets label: NDC 50991-783-60 ALA-HIST IR 2 mg Tablets Antihistamine Each tablet contains: Dexbrompheniramine Maleate.........2 mg 60 Tablets Usual Dosage: See product foldout for full prescribing information Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. Store at controlled room temperature 15°-30°C (59°-86°F). Manufactured for: Poly Pharmaceuticals Rev. 02/12 label insert" ], "set_id": "0d203b5c-8b10-428b-8703-17be6b4ce6eb", "id": "4513db4f-e8f2-ecc6-e063-6294a90a1b17", "effective_time": "20251203", "version": "11", "openfda": { "application_number": [ "M012" ], "brand_name": [ "ALA-HIST IR" ], "generic_name": [ "DEXBROMPHENIRAMINE MALEATE" ], "manufacturer_name": [ "Poly Pharmaceuticals, Inc." ], "product_ndc": [ "50991-783" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DEXBROMPHENIRAMINE MALEATE" ], "rxcui": [ "2262293", "2262295" ], "spl_id": [ "4513db4f-e8f2-ecc6-e063-6294a90a1b17" ], "spl_set_id": [ "0d203b5c-8b10-428b-8703-17be6b4ce6eb" ], "package_ndc": [ "50991-783-02", "50991-783-60" ], "is_original_packager": [ true ], "upc": [ "0350991783605" ], "unii": [ "BPA9UT29BS" ] } } ] }