说明与适用边界
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spl product data elements
NIGHT TIME SLEEP-AID Diphenhydramine HCl MICROCRYSTALLINE CELLULOSE ANHYDROUS DIBASIC CALCIUM PHOSPHATE STEARIC ACID CROSCARMELLOSE SODIUM SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE TRIACETIN FD&C RED NO. 40 ALUMINUM LAKE FD&C BLUE NO. 2 ALUMINUM LAKE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE Caplet DPZ
spl unclassified section
Drug Facts
Distributed by: Advanced Rx LLC 1942 NE 163rd St North Miami Beach, FL 33162 U.S.A. MADE IN THE USA
活性成分 / Active ingredient
Active ingredients (in each Caplet) Diphenhydramine HCl 25 mg
用途 / Purpose
Purpose Nighttime sleep-aid
适应证 / Indications and usage
Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
警告 / Warnings
Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin.
禁用事项 / Do not use
Do not use for 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 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. 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 • take only one dose (2 Caplets) per day (24 hours) adults & children 12 yrs & over 2 Caplets at bedtime if needed or as directed by a doctor children under 12 yrs do not use
dosage and administration table
<table width="100%"><tbody><tr><td>adults & children 12 yrs & over</td><td>2 Caplets at bedtime if needed or as directed by a doctor</td></tr><tr><td>children under 12 yrs</td><td>do not use</td></tr></tbody></table>
储存 / Storage and handling
Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) read all product information before using TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSIN
辅料 / Inactive ingredients
Inactive ingredients Microcrystalline Cellulose, Dicalcium Phosphate, Stearic Acid, Croscarmellose Sodium, Colloidal Silicon Dioxide, Hypromellose, Titanium Dioxide, Triacetin, FD&C Red No.40 Lake, FD&C Blue No.2 Aluminum Lake, Polysorbate.
questions
Questions or comments Call toll free 1-800-630-8895 Monday through Friday 9AM - 5PM EST
package label principal display panel
PRINCIPAL DISPLAY PANEL NDC 80513-383-22 Compare to the active indredient in VICKS ® ZzzQuil ® NIGHTTIME SLEEP-AID* NIGHT TIME SLEEP-AID Diphenhydramine HCl 25 mg 220 CAPLETS *This product is not manufactured or distributed by The The Procter & Gamble Company, owner of the registered trademark VICKS ® ZzzQuil ® NIGHTTIME SLEEP-AID label
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20250702
- 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.

