说明与适用边界
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spl product data elements
Sleep Aid diphenhydramine hydrochloride CARNAUBA WAX CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM OXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE DB
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredient (in each caplet) Diphenhydramine HCl 25 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 in 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 drowsiness will occur do not drive a motor vehicle or operate machinery 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. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
禁用事项 / Do not use
Do not use in 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 drowsiness will occur do not drive a motor vehicle or operate machinery
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.
用法用量原文 / Dosage and administration
Directions adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years do not use
dosage and administration table
<table width="55%" styleCode="Noautorules"> <col width="50%" align="left" valign="top"/> <col width="50%" align="left" valign="top"/> <tbody> <tr styleCode="Botrule"> <td styleCode="Rrule Toprule">adults and children 12 years and over</td> <td styleCode="Toprule">take 2 caplets at bedtime if needed, or as directed by a doctor</td> </tr> <tr> <td styleCode="Rrule">children under 12 years</td> <td>do not use</td> </tr> </tbody> </table>
储存 / Storage and handling
Other information each caplet contains: calcium 15 mg store between 20-25 ° C (68-77 ° F). Avoid high humidity. Protect from light. do not use if carton tape imprinted with "SAFETY SEAL®" is broken or missing or blister unit is torn or broken
辅料 / Inactive ingredients
Inactive ingredients carnauba wax, croscarmellose sodium, dibasic calcium phosphate, FD&C Blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
questions
Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
package label principal display panel
PRINCIPAL DISPLAY PANEL Sleep aid 36 Sleep aid 100
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20180514
- 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.

