说明与适用边界
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spl product data elements
fexofenadine hcl fexofenadine hcl ANHYDROUS LACTOSE SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE STEARIC ACID HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED FERRIC OXIDE RED TITANIUM DIOXIDE FERRIC OXIDE YELLOW FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SG;201 fexofenadine hcl fexofenadine hcl ANHYDROUS LACTOSE SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE STEARIC ACID HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED FERRIC OXIDE RED TITANIUM DIOXIDE FERRIC OXIDE YELLOW FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SG;202
活性成分 / Active ingredient
ALLERGY Active ingredient (in each film-coated tablet) Fexofenadine HCl USP 60 mg Fexofenadine HCl USP 180 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 kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) 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 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 do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions)
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 Directions (for 60mg) adults and children 12 years of age and over take one 60mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor Directions (for 180mg) adults and children 12 years of age and over take one 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor
dosage and administration table
<table><colgroup><col width="35%"/><col width="66%"/></colgroup><tbody><tr><td styleCode="Botrule Lrule Toprule" valign="top"><paragraph>adults and children 12 years of age and over</paragraph></td><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>take one 60mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours</paragraph></td></tr><tr><td styleCode="Botrule Lrule" valign="top"><paragraph>children under 12 years of age</paragraph></td><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>do not use</paragraph></td></tr><tr><td styleCode="Botrule Lrule" valign="top"><paragraph>adults 65 years of age and older</paragraph></td><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode="Botrule Lrule" valign="top"><paragraph>consumers with kidney disease</paragraph></td><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>
<table><colgroup><col width="35%"/><col width="66%"/></colgroup><tbody><tr><td styleCode="Botrule Lrule Toprule" valign="top"><paragraph>adults and children 12 years of age and over</paragraph></td><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>take one 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours</paragraph></td></tr><tr><td styleCode="Botrule Lrule" valign="top"><paragraph>children under 12 years of age</paragraph></td><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>do not use</paragraph></td></tr><tr><td styleCode="Botrule Lrule" valign="top"><paragraph>adults 65 years of age and older</paragraph></td><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode="Botrule Lrule" valign="top"><paragraph>consumers with kidney disease</paragraph></td><td styleCode="Botrule Lrule Rrule" valign="top"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>
储存 / Storage and handling
Other information store between 20° and 25°C (68° and 77°F) protect from excessive moisture each tablet contains: sodium 2.7 mg (for 60 mg), sodium 8.2 mg (for 180 mg) this product meets the requirements of USP Dissolution Test 2
辅料 / Inactive ingredients
Inactive ingredients anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide
questions
Questions or comments? Call toll-free 1-888-588-1418 Monday-Friday 9AM-7PM EST Distributed by: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.majorpharmaceuticals.com
package label principal display panel
Package/Label Principal Display Panel MAJOR ® NDC 0904-7192-04 Compare to the active ingredient in Allegra ® Allergy * Non-Drowsy Fexofenadine Hydrochloride Tablets, USP 60 mg Antihistamine 12-Hour Indoor/Outdoor Allergy Relief ◾ Sneezing ◾ Runny Nose ◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat 100 Tablets Allergy Relief MAJOR ® NDC 0904-7192-60 Compare to the active ingredient in Allegra ® Allergy * Non-Drowsy Fexofenadine Hydrochloride Tablets, USP 60 mg Antihistamine 12-Hour Indoor/Outdoor Allergy Relief ◾ Sneezing ◾ Runny Nose ◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat 100 Tablets Allergy Relief MAJOR ® NDC 0904-7192-40 Compare to the active ingredient in Allegra ® Allergy * Non-Drowsy Fexofenadine Hydrochloride Tablets, USP 60 mg Antihistamine 12-Hour Indoor/Outdoor Allergy Relief ◾ Sneezing ◾ Runny Nose ◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat 500 Tablets Allergy Relief MAJOR ® NDC 0904-7486-02 Compare to the active ingredient in Allegra ® Allergy 24 Hour Tablets * Non-Drowsy Fexofenadine Hydrochloride Tablets, USP 180 mg Antihistamine 24-Hour Indoor/Outdoor Allergy Relief ◾ Sneezing ◾ Runny Nose ◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat 30 Tablets Allergy Relief MAJOR ® NDC 0904-7486-60 Compare to the active ingredient in Allegra ® Allergy 24 Hour Tablets * Non-Drowsy Fexofenadine Hydrochloride Tablets, USP 180 mg Antihistamine 24-Hour Indoor/Outdoor Allergy Relief ◾ Sneezing ◾ Runny Nose ◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat 100 Tablets Allergy Relief MAJOR ® NDC 0904-7486-40 Compare to the active ingredient in Allegra ® Allergy 24 Hour Tablets * Non-Drowsy Fexofenadine Hydrochloride Tablets, USP 180 mg Antihistamine 24-Hour Indoor/Outdoor Allergy Relief ◾ Sneezing ◾ Runny Nose ◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat 500 Tablets Allergy Relief Fexofenadine-60mg-100s Fexofenadine-60mg-100s Fexofenadine-60mg-500s Fexofenadine-180mg-30s Fexofenadine-180mg-100s Fexofenadine-180mg-500s
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 6 / 20250812
- 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.

