说明与适用边界
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spl product data elements
dg health sleep aid Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARNAUBA WAX CROSPOVIDONE (120 .MU.M) DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 FD&C BLUE NO. 2 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 STEARIC ACID TITANIUM DIOXIDE Light Blue L431
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 may 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 may 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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="100%"><col width="34%"/><col width="44%"/><tbody><tr><td styleCode="Botrule Lrule Toprule " valign="top"><paragraph>adults and children 12 years and over</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>take 2 caplets at bedtime if needed, or as directed by a doctor</paragraph></td></tr><tr><td styleCode="Botrule Lrule " valign="top"><paragraph>children under 12 years</paragraph></td><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>do not use</paragraph></td></tr></tbody></table>
储存 / Storage and handling
Other information • each caplet contains: calcium 15 mg • store at 20-25 ° C (68-77 ° F). Avoid high humidity. Protect from light. • do not use if blister unit is broken or torn
辅料 / Inactive ingredients
Inactive ingredients carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide
questions
Questions or comments? 1-888-309-9030
package label principal display panel
Principal Display Panel Compare to the active ingredient of Simply Sleep ® Nighttime Sleep Aid Caplets Night Time Sleep Aid Diphenhydramine HCl 25 mg Helps you fall asleep Safe, non-habit forming 24 Caplets 25 mg Actual Caplet Size Does Not Contain Pain Reliever sleep aid image
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 8 / 20240717
- 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.

