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西药 · 美国药品标签原文

苯海拉明 · Sleep Aid

DIPHENHYDRAMINE HYDROCHLORIDE

Sleep Aid · Velocity Pharma LLC。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

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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.
核对原始来源