Fexofenadine Hydrochloride Tablets, USP 180 mg

Set ID
2a578643-adc1-44ca-83f2-9d48527bd3a4
Manufacturer
AMERISOURCE BERGEN | Sun Pharmaceutical Industries Limited
Effective date
2024-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:42

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each tablet)

Fexofenadine HCl, USP 180 mg

Purpose

Antihistamine

Uses

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

Warnings

Warnings

Directions And Dosage

Directions

adults and children 12 years of age and over take one 180 mg 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

Other Label Information

Other information

safety sealed: do not use if carton is opened or if inner safety seal is torn or missing store between 20° to 25°C (68° to 77°F) protect from excessive moisture

Inactive ingredients

croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide

Questions or comments?

Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555 .

PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton

NDC 46122-779-66 Compare to Allegra ® Allergy active ingredient* GOOD NEIGHBOR PHARMACY ® NON-DROWSY Fexofenadine Hydrochloride Tablets, USP 180 mg Antihistamine Indoor & Outdoor Allergies Allergy 24 Hours Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat 90 Tablets

Products

NDC Codes

Ingredients

NameUNIIKind
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
STARCH, CORNO8232NY3SJIACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl, USP 180 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over take one 180 mg 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

Other information

STORAGE AND HANDLING SECTION

safety sealed: do not use if carton is opened or if inner safety seal is torn or missing store between 20° to 25°C (68° to 77°F) protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555 .

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Distributed By: AmerisourceBergen 1 West First Avenue Conshohocken, PA 19428

PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 46122-779-66 Compare to Allegra ® Allergy active ingredient* GOOD NEIGHBOR PHARMACY ® NON-DROWSY Fexofenadine Hydrochloride Tablets, USP 180 mg Antihistamine Indoor & Outdoor Allergies Allergy 24 Hours Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat 90 Tablets

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc76ea7e25-e968-4c78-9eca-ac960ad55985.xml2024-05-18
otcfexofenadine-01.jpg2024-05-18