说明与适用边界
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spl product data elements
DYE-FREE CHILDRENS LORATADINE LORATADINE ASPARTAME ANHYDROUS CITRIC ACID SILICON DIOXIDE MAGNESIUM STEARATE MANNITOL MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID LORATADINE LORATADINE white to off-white bevelled edge LC5
spl unclassified section
Drug Facts
Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 0420
活性成分 / Active ingredient
Active ingredient (in each chewable tablet) 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 sneezing itchy, watery eyes 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. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
禁用事项 / Do not use
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 right away (1-800-222-1222).
用法用量原文 / Dosage and administration
Directions chew or crush tablets completely before swallowing. adults and children 6 years and over chew 2 tablets daily; not more than 2 chewable tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 chewable tablet 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 width="97.76%"><colgroup><col width="32%"/><col width="66%"/></colgroup><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>adults and children 6 years and over</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>chew 2 tablets daily; not more than 2 chewable tablets in 24 hours</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>children 2 to under 6 years of age</paragraph></td><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>chew 1 tablet daily; not more than 1 chewable tablet in 24 hours</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>children under 2 years of age</paragraph></td><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>consumers with liver or kidney disease</paragraph></td><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>
储存 / Storage and handling
Other information phenylketonurics: contains phenylalanine 1.25 mg per tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20° to 25°C (68° to 77°F).
辅料 / Inactive ingredients
Inactive ingredients aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
questions
Questions? call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984 . Keep the carton. It contains important information. See end panel for expiration date.
最近修订 / Recent changes
package label principal display panel
PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton NDC 51660-726-30 † Compare to the active ingredient of Children's Claritin ® Chewable Ages 2+ years Children's Loratadine Chewable Tablets USP, 5 mg Antihistamine Indoor & Outdoor Allergies 30 CHEWABLE TABLETS The chewable tablets are to be chewed before swallowing. Dye-Free Grape Flavored Non-Drowsy* 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose *When taken as directed. See Drug Facts Panel. †Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners. 30ct
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 1 / 20240315
- 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.

