说明与适用边界
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spl product data elements
Somnapure Clinical Strength Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE FERRIC OXIDE YELLOW 44687
活性成分 / Active ingredient
Drug Facts Active ingredient (in each caplet) Diphenhydramine HCl 50 mg
用途 / Purpose
Purpose Nighttime sleep aid
适应证 / Indications and usage
Use helps to reduce difficulty in falling asleep
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 difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product , avoid alcoholic beverages. 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 breastfeeding, 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 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 difficulty in urination due to enlargement of the 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 beverages.
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 breastfeeding, 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 and over: take 1 caplet at bedtime if needed or as directed by a doctor Children under 12 years: do not use.
其他安全资料 / Other safety information
Other information each caplet contains : calcium 50 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number. protect from moisture
辅料 / Inactive ingredients
Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silcon dioxide, stearic acid, talc, titanium dioxide, yellow iron oxide
questions
Questions of comments? Call 1-855-606-6507
package label principal display panel
Principal display panel Force Factor Somnapure Clinical Strength Nighttime Sleep Aid / Diphenhydramine HCl #1 Doctor-Recommended Ingredient Fall Asleep Quickly Wake Up Energized Non-Habit-Forming 30 Caplets One Caplet per Dose label box
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 4 / 20241206
- 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.

