说明与适用边界
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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.

