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

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 180 mg

Medication Information

Warnings

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

Other Information

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

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.

Description

Fexofenadine HCl USP, 180 mg

Principal Display Panel

Fexofenadine HCl USP, 180 mg

NDC 54868-6289-0

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

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

Do Not Use

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

Active Ingredient(s)

Fexofenadine HCl USP, 180 mg

Pregnancy/breastfeeding

ask a health professional before use.

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

Warnings

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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Principal Display Panel

Fexofenadine HCl USP, 180 mg

NDC 54868-6289-0

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

Storage

store between 20° - 25°C (68° - 77°F)

protect from excessive moisture

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

Do Not Use (Do not use)

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

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

Fexofenadine HCl USP, 180 mg

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

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

[{"name": "FEXOFENADINE", "unii": "E6582LOH6V", "classCode": "ACTIB", "strengthNumerator": "180", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "magnesium stearate", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "mannitol", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POWDERED CELLULOSE", "unii": "SMD1X3XO9M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (6 MPA.S)", "unii": "0WZ8WG20P6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE BLACK", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "polyethylene glycol 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "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", "Questions": "call toll-free 1-888-375-3784 Manufactured by: Dr. Reddy’s Laboratories Louisiana LLC, 8800 Line Ave Shreveport, LA, 71106. OR 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."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

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