说明与适用边界
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spl product data elements
Sleep Aid Diphenhydramine HCL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 GELATIN GLYCERIN LIGHT MINERAL OIL POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITAN SORBITOL LECITHIN, SOYBEAN MANNITOL PC5
活性成分 / Active ingredient
Active ingredient (in each softgel) Diphenhydramine HCl 50 mg
用途 / Purpose
Purpose Nighttime sleep-aid
适应证 / Indications and usage
Use 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 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 Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product avoid alcoholic drinks. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 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 persists 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 (1-800-222-1222) 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
储存 / Storage and handling
Other information store at 15-30°C (59°-86°F)
辅料 / Inactive ingredients
Inactive ingredients FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol, sorbitan, white ink
questions
Questions or comments? 1- 800-632-6900
package label principal display panel
Principal Display Panel COMPARE TO THE ACTIVE INGREDIENT IN UNISOM SLEEPGELS®* Nighttime Sleep-Aid Diphenhydramine HCl 50 mg Nighttime Sleep-Aid FALL ASLEEP FAST, SLEEP SOUNDLY, WAKE REFRESHED SOFTGELS ONE SOFTGEL PER DOSE *UNISOM SLEEPGELS® is a registered trademark of Chattem, Inc. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202
Package Label KROGER HEALTH Nighttime Sleep-Aid Diphenhydramine HCl 50 mg
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 7 / 20260325
- 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.

