Med SciforuMed Sciforu

Interface in English. Medical references retain their original language; bilingual names and selected translations are provided.

西药 · 美国药品标签原文

苯海拉明 · DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE · SOFTGEL HEALTHCARE PRIVATE LIMITED。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

此页按所列地区、版本归档。标签内容可能更新,具体产品请核对原始来源;本站关联表示阅读线索,不表示药品与器械可兼容或可替换。

spl product data elements

DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE POLYETHYLENE GLYCOL 600 WATER PROPYLENE GLYCOL POLYETHYLENE GLYCOL 400 SORBITOL FD&C BLUE NO. 1 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE GELATIN GLYCERIN (Transparent) (Oval)

活性成分 / Active ingredient

Active ingredient (in each softgel) Diphenhydramine Hydrochloride USP 50 mg

用途 / Purpose

Purpose Nighttime sleep-aid

适应证 / Indications and usage

Uses for relief of occasional sleeplessness

警告 / Warnings

Warnings Do not use for children under 12 years of age 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 a breathing problem such as emphysema or chronic bronchitis glaucoma 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 avoid alcoholic drinks

停用事项 / Stop use

Stop use and ask a doctor if sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

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 softgel (50 mg) at bedtime if needed, or as directed by a doctor

辅料 / Inactive ingredients

Inactive ingredients Propylene Glycol, Polyethylene Glycol 600, Polyethylene Glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD & C Blue No.1, Purified Water

package label principal display panel

Principal Display Panel Compare to the active ingredient Unisom ® SleepGels ® SleepGels NDC 35916-0438-1 Diphenhydramine Hydrochloride Capsules USP 50 mg NIGHTTIME SLEEP-AID ♦ fall asleep fast ♦ sleep soundly ♦ safe, non-habit forming 100 SoftGels** **liquid-filled capsules one softgel per dose bottle Bulk Package Label label

来源、版本与许可

资料类型
美国药品标签原文
版本
4 / 20260127
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