FDA.reportPublic FDA data

Fexofenadine HCl Tablets USP

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2022-02-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:09:20

Key Label Information#

Active Ingredients And Purpose

Active ingredient(s)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Uses

Use(s)

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

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide

Questions?

Call 1-888-375-3784

Label Images#

68071-5191-3
68071-5191-3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5191-32022-02-07C16284748780-1d6a99b39-bbbf-a426-e053-dadaa90af4c2Fexofenadine HCl Tablets USP
68071-5191-32022-01-28C16284748780-1d6a99b39-bbbf-a426-e053-dadaa90af4c2Fexofenadine HCl Tablets USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-784-01EA - Each55111-784fcfbe779-dfaf-4c1a-b197-12b0a5ca524712018-12-13
55111-784-30EA - Each55111-7849ca6ce31-a274-408f-b03e-0b74b74bc4fd12015-09-10

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-519168071-5191-3
55111-784

Ingredients#

Name, UNII, Kind table
NameUNIIKind
POWDERED CELLULOSESMD1X3XO9MIACT
FD&C RED NO. 40WZB9127XOAIACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STARCH, CORNO8232NY3SJIACT
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT

Complete SPL Sections#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP, 180 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use(s)

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

SPL UNCLASSIFIED SECTION

safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing store between 20° and 25°C (68° and 77°F) protect from excessive moisture this product meets the requirements of USP Dissolution Test 4

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call 1-888-375-3784

Source Document#

Source XML · Source PDF

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076502-001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2006-04-11
A076502-002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2006-04-11
A076502-003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2006-04-11
A076502-004CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-12
A076502-005CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2011-04-12
A076502-006FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-12
A076502-007FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2011-04-12
A076502-008FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-04-12
A076502-009FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2011-04-12