说明与适用边界
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spl product data elements
Cetirizine HCl Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE C;13 Cetirizine HCl Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE C;17 Cetirizine HCl Cetirizine Cetirizine HCl Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE C;13 Cetirizine HCl Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE C;13 Cetirizine HCl Cetirizine Cetirizine HCl Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE C;17 Cetirizine HCl Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE C;17
活性成分 / Active ingredient
Cetirizine HCl 5 mg Cetirizine HCl 10 mg
用途 / 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 or an antihistamine containing hydroxyzine Ask a doctor before useif you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: • If breast-feeding: not recommended • if pregnant: 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)
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 Cetirizine Hydrochloride Tablets, USP 5 mg adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10) once daily depending upon severity of symptoms; do not take more than 2 tablets (10) in 24 hours. adults 65 years and over 1 tablet (5 mg) once a day; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Cetirizine Hydrochloride Tablets, USP 10 mg adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
dosage and administration table
<table width="100%"><col width="50%"/><col width="50%"/><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>1 tablet (5 mg) or 2 tablets (10) once daily depending upon severity of symptoms; do not take more than 2 tablets (10) in 24 hours.</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>adults 65 years and over</paragraph></td><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1 tablet (5 mg) once a day; do not take more than 1 tablet (5 mg) in 24 hours.</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>children under 6 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>
<table width="100%"><col width="50%"/><col width="50%"/><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>one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.</paragraph><paragraph>A 5 mg product may be appropriate for less severe symptoms.</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>adults 65 years and over</paragraph></td><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>children under 6 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>
spl unclassified section
Other information • store between 20°C to 25°C (68°F to 77°F) • do not use of imprinted foil inner seal on bottle is broken or missing. • FDA approved organic impurities test procedure differs from USP
辅料 / Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
其他安全资料 / Other safety information
Questions or comments? Call toll-free weekdays 9 AM to 5 PM EST at 1 (888) 721-7115. Distributed by: Glenmark Therapeutics Inc., USA Elmwood Park, NJ 07407 www.glenmarkpharma-us.com August 2026
package label principal display panel
Package/Label Principal Display Panel Container label NDC 72657-129-35 10 mg - 365 Tablets label10mg365s
Principal Display Panel Carton label NDC 72657-129-35 10 mg - 365 Tablets carton10mg365s
Package/Label Principal Display Panel label10mg365s1
Package/Label Principal Display Panel carton10mg365s1
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 7 / 20260807
- 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.

