说明与适用边界
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spl product data elements
Nighttime Sleep-aid Diphenhydramine HCl SILICON DIOXIDE CROSCARMELLOSE SODIUM CELLULOSE, MICROCRYSTALLINE CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS MAGNESIUM STEARATE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 93XF;57344
活性成分 / Active ingredient
Active ingredient (in each caplet) Diphenhydramine Hydrochloride 25mg
用途 / Purpose
Purpose Nighttime Sleep-aid
适应证 / Indications and usage
Uses relieves occasional sleeplessness
警告 / Warnings
Warnings Do not use • in children under 12 years of age • with any other product containing diphenhydramine, including one used on skin Ask a doctor before use if you have • a breathing problem such as emphysema, asthma, 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 produc t • avoid alcoholic beverages • drowsiness will occur • avoid driving a motor vehicle or operating machinery Stop use and ask a doctor if • sleeplessness persists continuously for more than two 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 right away.
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 and over: take two caplets at bedtime if needed, or as directed by a doctor • do not exceed recommended dose
储存 / Storage and handling
Other information each caplet contains: calcium 85mg store at 20°C-25°C (68°F-77°F) Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
辅料 / Inactive ingredients
Inactive ingredients calcium phosphate, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silica.
package label principal display panel
package label 1
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 6 / 20250514
- 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.

