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西药 · 美国药品标签原文

Banophen

DIPHENHYDRAMINE HCL

Banophen · Preferred Pharmaceuticals Inc.。此记录对应特定产品,标签收录不代表所有用途获批。

说明与适用边界

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spl product data elements

Banophen diphenhydramine hcl D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED LACTOSE MONOHYDRATE ANHYDROUS LACTOSE STARCH, CORN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CPC;836

活性成分 / Active ingredient

Active Ingredient (in each banded capsule) Diphenhydramine Hydrochloride 50 mg

用途 / Purpose

Purpose Antihistamine

适应证 / Indications and usage

Use Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies • runny nose • sneezing • itchy, watery eyes • itchy throat and nose • Temporarily relieves these symptoms due to the common cold o runny nose o sneezing

警告 / Warnings

WARNINGS Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin

咨询医生 / Ask a doctor

Ask a doctor before use if you have • glaucoma • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland

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

使用中 / When using

When using this product • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children

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 • Take every 4-6 hours • Do not take more than 6 doses in 24 hours adults and children 12 years of age and over Take 1 capsule (50 mg) children under 12 years of age ask a doctor, the proper dosage strength is not available in this package** **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

dosage and administration table

<table width="100%"><col width="50%"/><col width="50%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>adults and children 12 years of age and over</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>Take 1 capsule (50 mg)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>children under 12 years of age </paragraph></td><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>ask a doctor, the proper dosage strength is not available in this package**</paragraph></td></tr><tr><td colspan="2" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.</paragraph></td></tr></tbody></table>

spl unclassified section

Other Information • Store at room temperature, USP. • Do not use if either capsule band or imprinted safety seal under cap is broken or missing • Protect from moisture • Contains lactose Distributed by MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 Repackaged By: Preferred Pharmaceuticals Inc. NDC 68788-7830

辅料 / Inactive ingredients

Inactive Ingredients D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

questions

Questions? Questions or comments? (800) 616-2471

package label principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Diphenhydramine HCL Capsules USP 50mg

来源、版本与许可

资料类型
美国药品标签原文
版本
5 / 20260406
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.
核对原始来源