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西药 · 美国药品标签原文

OLOPATADINE HYDROCHLORIDE

OLOPATADINE HYDROCHLORIDE

OLOPATADINE HYDROCHLORIDE · GLENMARK THERAPEUTICS INC., USA。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

OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE Olopatadine BENZALKONIUM CHLORIDE EDETATE DISODIUM HYDROCHLORIC ACID POVIDONE K30 SODIUM CHLORIDE SODIUM HYDROXIDE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS WATER

活性成分 / Active ingredient

Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine

active ingredient table

<table cellpadding="0.4pt" cellspacing="0pt" width="95.98%"><col width="54%"/><col width="40%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold"><content styleCode="italics">Active Ingredients</content></content></paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption><content styleCode="bold"><content styleCode="italics">Purpose</content></content></item></list></td></tr><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>Antihistamine</paragraph></td></tr></tbody></table>

用途 / Purpose

Active Ingredients Purpose Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%) Antihistamine

purpose table

<table cellpadding="0.4pt" cellspacing="0pt" width="95.98%"><col width="54%"/><col width="40%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold"><content styleCode="italics">Active Ingredients</content></content></paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption><content styleCode="bold"><content styleCode="italics">Purpose</content></content></item></list></td></tr><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>Antihistamine</paragraph></td></tr></tbody></table>

适应证 / Indications and usage

Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

警告 / Warnings

Warnings For external use only

禁用事项 / Do not use

Do not use • if solution changes color or becomes cloudy • if you are sensitive to any ingredient in this product • to treat contact lens related irritation When using this product • do not touch tip of container to any surface to avoid contamination • remove contact lenses before use • wait at least 10 minutes before reinserting contact lenses after use • do not wear a contact lens if your eye is red

停用事项 / Stop use

Stop use and ask a doctor if you experience: • eye pain • changes in vision • increased redness of the eye • itching worsens or lasts for more than 72 hours

儿童安全 / Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

用法用量原文 / Dosage and administration

Directions • adults and children 2 years of age and older: o put 1 drop in the affected eye(s) once daily, no more than once per day o if using other ophthalmic products while using this product, wait at least 5 minutes between each product o replace cap after each use • children under 2 years of age: consult a doctor

储存 / Storage and handling

Other information • only for use in the eye • store between 2°C to 25°C (36°F to 77°F)

辅料 / Inactive ingredients

Inactive ingredients benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (to adjust pH), povidone, sodium chloride and water for injection

questions

Questions? Call weekdays 9 AM to 6 PM EST at 1 (888) 721-7115. Distributed by: Glenmark Therapeutics Inc., USA Elmwood Park, NJ 07407 Product of Spain 07/2025

package label principal display panel

PRINCIPAL DISPLAY PANEL NDC 72657-194-25 Olopatadine HCl Ophthalmic Solution 0.2% Antihistamine Once Daily STERILE 2.5 mL (0.085 FL OZ) NDC: 72657-194-25 Original Prescription Strength ONCE DAILY Olopatadine HCl Ophthalmic Solution, USP 0.2% Antihistamine Eye Allergy Itch Relief STERILE 2.5 mL (0.085 FL OZ) label carton

来源、版本与许可

资料类型
美国药品标签原文
版本
3 / 20260127
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