说明与适用边界
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spl product data elements
EZ Nite Sleep Diphenhyramine Hydrochloride PROPYLENE GLYCOL POLYETHYLENE GLYCOL 400 SHELLAC WATER TITANIUM DIOXIDE FD&C RED NO. 40 GELATIN SORBITOL SOLUTION FD&C BLUE NO. 1 SORBITAN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 121 oblong shaped Purple,translucent
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredient (in each softgel) Diphenhydramine HCl 25 mg
用途 / Purpose
Purpose Nighttime sleep-aid
适应证 / Indications and usage
Uses ■ for the relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep
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. Do not use ■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin. Ask a doctor before use if you have ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma ■ difficulty in urination 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 ■ avoid alcoholic beverages Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. 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 (1-800-222-1222) right away.
禁用事项 / Do not use
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 ■ difficulty in urination due to enlargement of the 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 beverages
停用事项 / Stop use
Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of 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 (1-800-222-1222) right away.
用法用量原文 / Dosage and administration
Directions ■ take only one dose per day (24 hours) adults & children 12 yrs & over 2 softgels at bedtime if needed or as directed by a doctor children under 12 yrs do not use
dosage and administration table
<table border="0" width="100%"><tbody><tr><td> adults & children 12 yrs & over </td><td>2 softgels at bedtime if needed or as directed by a doctor</td></tr><tr><td>children under 12 yrs</td><td>do not use</td></tr></tbody></table>
其他安全资料 / Other safety information
Other information ■ store at 20-25° C (68-77°F) ■ avoid excessive heat above 40°C (104°F) ■ protect from light
辅料 / Inactive ingredients
Inactive ingredients FD&C blue no. 1, FD&C red no. 40, gelatin, polyethylene glycol 400, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide.
questions
Questions or comments? Call 1-800-632-6900
package label principal display panel
diphenhydramine-sg-24s-ifc
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20240417
- 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.

