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西药 · 美国药品标签原文

NIGHT TIME SLEEP-AID

DIPHENHYDRAMINE HCL

NIGHT TIME SLEEP-AID · Advanced Rx 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

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 &amp; children 12 yrs &amp; 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.
核对原始来源