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西药 · 美国药品标签原文

Meclizine HCL

MECLIZINE HCL 25MG CHEWABLE TABLETS

Meclizine HCL · Aphena Pharma Solutions - Tennessee, 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

此页按所列地区、版本归档。标签内容可能更新,具体产品请核对原始来源;本站关联表示阅读线索,不表示药品与器械可兼容或可替换。

spl product data elements

Meclizine HCL Meclizine HCl 25mg Chewable Tablets ASPARTAME CROSCARMELLOSE SODIUM DEXTROSE FD&C RED NO. 40 RASPBERRY MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SUCROSE MECLIZINE HYDROCHLORIDE MECLIZINE AP;115

活性成分 / Active ingredient

Active ingredient Meclizine Hydrochloride 25 mg

用途 / Purpose

Purpose Antiemetic

适应证 / Indications and usage

Uses For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor

警告 / Warnings

Warnings Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an elarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives and tranquilizers may increse drowsiness be careful when driving a moor vehicle or operating machinery

用法用量原文 / Dosage and administration

Directions take dose one hour before travel starts tablets can be chewed or swallowed whole with water adults & children 12 years and over: take 1-2 tablets once daily children under 12 years: ask a doctor

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.

其他安全资料 / Other safety information

OTHER INFORMATION Phenylketonurics: each tablet contains: phenylalanine 0.28 mg store at room temparature 15 - 30 °C

questions

Questions or Comments Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

辅料 / Inactive ingredients

Inactive ingredients Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

spl unclassified section

Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 25 mg 30 71610-0528-30 90 71610-0528-60 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20210415JH Aphena Pharma Solutions - TN

spl unclassified section table

<table border="0" cellpadding="1" cellspacing="1" width="28%"><col width="10%"/><col/><tbody><tr styleCode="Toprule"><td align="center" styleCode="bold" valign="bottom">Count</td><td align="center" valign="bottom"><content styleCode="bold">25 mg</content></td></tr><tr><td align="center" valign="bottom">30</td><td align="center">71610-0528-30</td></tr><tr><td align="center" valign="bottom">90</td><td align="center">71610-0528-60</td></tr></tbody></table>

package label principal display panel

PRINCIPAL DISPLAY PANEL - 25 mg NDC 71610-528 - Meclizine HCl 25 mg Chewable Tablets Bottle Label 25 mg

来源、版本与许可

资料类型
美国药品标签原文
版本
2 / 20250109
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