说明与适用边界
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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
活性成分 / Active ingredient
Drug Facts Active ingredients (in each tablet) Dexbrompheniramine Maleate 2 mg Purpose Antihistamine
用途 / Purpose
Purpose Antihistamine
适应证 / 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
警告 / 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.
咨询医药人员 / Ask a 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.
使用中 / 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.
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
儿童安全 / 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.
用法用量原文 / 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
<table width="500px"><col/><col/><tbody><tr><td valign="top">Adults and children 12 years of age and over: </td><td valign="top">1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours. </td></tr><tr><td valign="top">Children 6 to under 12 years of age: </td><td valign="top">1/2 tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours. </td></tr><tr><td valign="top">Children under 6 years of age: </td><td valign="top">Consult a doctor. </td></tr></tbody></table>
储存 / 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.
辅料 / Inactive ingredients
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
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 11 / 20251203
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

