Fexofenadine Hcl Tablets Usp

SPL v1

SPL

SPL Set ID dda452db-25a0-4409-96dd-a13ee73eba0b

Route

ORAL

Published

Effective Date 2011-09-07

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) Ferric Oxide Black Polyethylene Glycol 400 Titanium Dioxide Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: 194;R Shape: oval Color: pink Size: 7 mm Score: 1

Marketing Status

ANDA Active Since 2011-07-27

Description

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 180 mg

Use(s)

temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies:

runny nose
itchy, watery eys
sneezing
itching of the nose or Throad

Section 42229-5

Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, OK 74146

Storage

store between 20° - 25°C (68° - 77°F)

protect from excessive moisture

Warnings

Questions

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Louisiana LLC,

8800 Line Ave Shreveport, LA, 71106.

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachepalli - 502 325 INDIA

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.

Other Information

safety sealed: do not use if carton is opened or if individual blister units are torn or opened.

Active Ingredient(s)

Fexofenadine HCl USP, 180 mg

Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, mannitol, and powdered cellulose, opadry pink 03B54504 containing FD&C Red no. 40, hypromellose, iron oxide black, polyethylene glycol and titanium dioxide.

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

Fexofenadine HCl USP, 180 mg

NDC 54868-6289-0

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)

Ask A Doctor Before Use If

you have kidney disease. Your doctorshould determine if you need a different dose.

Stop Use and Ask Doctor If

Allergy

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

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Structured Label Content

Use(s)

temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies:

runny nose
itchy, watery eys
sneezing
itching of the nose or Throad

Section 42229-5 (42229-5)

Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, OK 74146

Purpose

Antihistamine

Storage

store between 20° - 25°C (68° - 77°F)

protect from excessive moisture

Warnings

Questions

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Louisiana LLC,

8800 Line Ave Shreveport, LA, 71106.

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachepalli - 502 325 INDIA

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.

Other Information (Other information)

safety sealed: do not use if carton is opened or if individual blister units are torn or opened.

Active Ingredient(s) (Active ingredient(s))

Fexofenadine HCl USP, 180 mg

Inactive Ingredients (Inactive ingredients)

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel

Fexofenadine HCl USP, 180 mg

NDC 54868-6289-0

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)

Ask A Doctor Before Use If (Ask a doctor before use if)

you have kidney disease. Your doctorshould determine if you need a different dose.

Stop Use and Ask Doctor If (Stop use and ask doctor if)

Allergy

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

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.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:20.371968 · Updated: 2026-03-14T22:52:50.897919