Fexofenadine Hcl Tablets Usp

SPL v4

SPL

SPL Set ID cafb5240-6bc1-1bf5-f12f-00d9502d75fe

Route

ORAL

Published

Effective Date 2017-11-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (180 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Magnesium Stearate Mannitol Powdered Cellulose Fd&c Red No. 40 Hypromellose 2910 (6 Mpa.s) Ferrosoferric Oxide Polyethylene Glycol 400 Titanium Dioxide Starch, Corn

Identifiers & Packaging

Marketing Status

ANDA Active Since 2018-02-20

Description

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 180 mg

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

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

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

Questions?

call 1-888-375-3784

Other Information

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 2

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 titantium dioxide

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 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.

Package Label 90 Count Label

Good Neighbor Pharmacy^®

NDC 46122-462-75

Allergy Relief

fexodenadine hydrochloride tablets,

180 mg

Antihistamine

24-Hour

Indoor and Outdoor Allergies Non-Drowsy

Package Label 90 Count Carton

Good Neighbor Pharmacy^®

Compare to the active ingredient in Allegra^®Allergy 24 Hour Tablets*

NDC 46122-462-75

Allergy Relief

fexodenadine hydrochloride

tablets, 180 mg

Antihistamine

Relief of:

Sneezine
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

Indoor and Outdoor

Allergies

Non-Drowsy

24

HOUR

Active Ingredient (in Each Tablet)

Fexofenadine HCl USP, 180 mg

Ask A Doctor Before Use If You Have

kidney disease. Your doctor should determine if you need a different dose.

Structured Label Content

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

Purpose

Antihistamine

Warnings

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

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients.

Questions?

call 1-888-375-3784

Other Information (Other information)

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 2

Inactive Ingredients (Inactive ingredients)

When Using This Product (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 Doctor If (Stop use and ask doctor if)

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

Package Label 90 Count Label (Package Label - 90 Count Label)

Good Neighbor Pharmacy^®

NDC 46122-462-75

Allergy Relief

fexodenadine hydrochloride tablets,

180 mg

Antihistamine

24-Hour

Indoor and Outdoor Allergies Non-Drowsy

Package Label 90 Count Carton (Package Label - 90 Count Carton)

Good Neighbor Pharmacy^®

Compare to the active ingredient in Allegra^®Allergy 24 Hour Tablets*

NDC 46122-462-75

Allergy Relief

fexodenadine hydrochloride

tablets, 180 mg

Antihistamine

Relief of:

Sneezine
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

Indoor and Outdoor

Allergies

Non-Drowsy

24

HOUR

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Fexofenadine HCl USP, 180 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

kidney disease. Your doctor should determine if you need a different dose.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Antihistamine", "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", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients.", "Questions?": "call 1-888-375-3784", "Other information": "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 2", "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 titantium dioxide", "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 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.", "Package Label - 90 Count Label": "Good Neighbor Pharmacy ® NDC 46122-462-75 Allergy Relief fexodenadine hydrochloride tablets, 180 mg Antihistamine 24-Hour Indoor and Outdoor Allergies Non-Drowsy", "Package Label - 90 Count Carton": "Good Neighbor Pharmacy ® Compare to the active ingredient in Allegra ® Allergy 24 Hour Tablets* NDC 46122-462-75 Allergy Relief fexodenadine hydrochloride tablets, 180 mg Antihistamine Relief of: Sneezine Runny Nose Itchy, Watery Eyes Itchy Nose or Throat Indoor and Outdoor Allergies Non-Drowsy 24 HOUR", "Active ingredient (in each tablet)": "Fexofenadine HCl USP, 180 mg", "Ask a doctor before use if you have": "kidney disease. Your doctor should determine if you need a different dose."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:58.395443 · Updated: 2026-03-14T23:01:12.726296