Fexofenadine Hcl Tablets Usp, 60 Mg And 180 Mg

Fexofenadine Hcl Tablets Usp, 60 Mg And 180 Mg
SPL v7
SPL
SPL Set ID 3151bc6d-b40b-4200-a5cf-e57b6791d92a
Route
ORAL
Published
Effective Date 2018-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (60 mg)
Inactive Ingredients
Croscarmellose Sodium Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow Hypromellose 2910 (15 Mpa.s) Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 6000 Silicon Dioxide Starch, Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G6 Shape: oval Color: orange Size: 12 mm Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2020-12-18
Description

Fexofenadine HCl USP 60 mg (for 60 mg) Fexofenadine HCl USP 180 mg (for 180 mg)

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP 60 mg (for 60 mg) Fexofenadine HCl USP 180 mg (for 180 mg)

Use(s)

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



  • runny nose
  • itchy, water eyes
  • sneezing
  • itching of the nose or throat
Warnings

Do not use

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



Ask a doctor before use if you have

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



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 a 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.

Directions
adults and children 12 years of age and over  take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours (for 60 mg)

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg) 
 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 foil printed with granules logo under bottle cap is opened or torn.
  • Do not use if carton is opened or if individual blister units are torn or opened.
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture
Active Ingredient(s)

Fexofenadine HCl USP 60 mg (for 60 mg)



Fexofenadine HCl USP 180 mg (for 180 mg)

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide.

Questions Or Comments

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST



Manufactured By:

Granules India Limited    

Hyderabad-500 081, India

MADE IN INDIA



Distributed By:

Granules USA, Inc.

Parsippany, NJ 07054

Principal Display Panel







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) (USE(S))

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



  • runny nose
  • itchy, water eyes
  • sneezing
  • itching of the nose or throat
Purpose (PURPOSE)

Antihistamine

Warnings (WARNINGS)

Do not use

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



Ask a doctor before use if you have

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



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 a 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.

Directions (DIRECTIONS)
adults and children 12 years of age and over  take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours (for 60 mg)

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg) 
 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 foil printed with granules logo under bottle cap is opened or torn.
  • Do not use if carton is opened or if individual blister units are torn or opened.
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture
Active Ingredient(s) (ACTIVE INGREDIENT(S))

Fexofenadine HCl USP 60 mg (for 60 mg)



Fexofenadine HCl USP 180 mg (for 180 mg)

Inactive Ingredients (INACTIVE INGREDIENTS)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide.

Questions Or Comments (QUESTIONS OR COMMENTS)

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST



Manufactured By:

Granules India Limited    

Hyderabad-500 081, India

MADE IN INDIA



Distributed By:

Granules USA, Inc.

Parsippany, NJ 07054

Principal Display Panel (PRINCIPAL DISPLAY PANEL)







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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:25.129325 · Updated: 2026-03-14T23:10:50.302579