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西药 · 美国药品标签原文

Loratadine

LORATADINE ORAL

Loratadine · Aurohealth 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

Loratadine Loratadine Oral LORATADINE LORATADINE GRAPE ASCORBIC ACID GLYCERIN MALTITOL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE PHOSPHORIC ACID PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM METABISULFITE SORBITOL SUCRALOSE colorless to light yellow

活性成分 / Active ingredient

Drug Facts Active ingredient (in each 5 mL) Loratadine USP 5 mg

用途 / Purpose

Purpose Antihistamine

适应证 / Indications and usage

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat

警告 / Warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

咨询医生 / Ask a doctor

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

使用中 / When using

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

停用事项 / Stop use

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

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 (1-800-222-1222) right away.

用法用量原文 / Dosage and administration

Directions use only with enclosed dosing cup mL = milliliter adults and children 6 years and over 10 mL daily; do not take more than 10 mL in 24 hours children 2 to under 6 years of age 5 mL daily; do not take more than 5 mL in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

dosage and administration table

<table cellspacing="0" cellpadding="0" border="0" width="599.564"><colgroup><col width="50%"/><col width="50%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="middle">adults and children 6 years and over </td><td styleCode="Rrule" align="center" valign="middle">10 mL daily; do not take more than 10 mL in 24 hours </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="middle">children 2 to under 6 years of age </td><td styleCode="Rrule" align="center" valign="middle">5 mL daily; do not take more than 5 mL in 24 hours </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="center" valign="middle">children under 2 years of age </td><td styleCode="Rrule" align="center" valign="middle">ask a doctor </td></tr><tr><td styleCode="Lrule Rrule" align="center" valign="middle">consumers with liver or kidney disease </td><td styleCode="Rrule" align="center" valign="middle">ask a doctor </td></tr></tbody></table>

储存 / Storage and handling

Other information each 5 mL contains : sodium 6 mg do not use if carton is opened, or if cap safety seal is broken or missing. store at 20° to 25°C (68° to 77°F)

辅料 / Inactive ingredients

Inactive ingredients artificial flavors, ascorbic acid, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose.

questions

Questions or comments? Call 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India

package label principal display panel

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle) AUROHEALTH NDC 58602-423-11 Ages 2 years and older Loratadine Oral Solution USP 5 mg/5 mL Antihistamine Non-Drowsy* 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Do not use if carton is opened, or if cap safety seal is broken or missing. Dye-Free Sugar-Free Alcohol Free Indoor & Outdoor Allergies Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. * When taken as directed. See Drug Facts Panel. Grape Flavor 2 FL OZ (60 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL) AUROHEALTH NDC 58602-423-11 # Compare to the active ingredient in children’s Claritin ® Ages 2 years and older Loratadine Oral Solution USP 5 mg/5 mL Antihistamine Non-Drowsy* 24 Hour Relief of: Sneezing Runny Nose Itchy,watery Eyes Itchy Throat or Nose Indoor & Outdoor Allergies Dosing Cup Included Dye-Free Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. * When taken as directed. See Drug Facts Panel. Grape Flavor 2 FL OZ (60 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL)

来源、版本与许可

资料类型
美国药品标签原文
版本
6 / 20250120
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