Fexofenadine Hcl Tablets Usp 180 Mg

Fexofenadine Hcl Tablets Usp 180 Mg
SPL v2
SPL
SPL Set ID 1e46343f-d6b6-73ba-e063-6394a90acd94
Route
ORAL
Published
Effective Date 2024-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Ferrosoferric Oxide Ferric Oxide Red Hypromellose 2910 (15 Mpa.s) Titanium Dioxide Ferric Oxide Yellow Croscarmellose Sodium Microcrystalline Cellulose Lactose Monohydrate Magnesium Stearate Polyethylene Glycol 6000 Starch, Corn Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G6 Shape: oval Color: orange Size: 12 mm
Marketing Status
ANDA Active Since 2024-07-27
Description

Fexofenadine HCl USP 180 mg

Purpose

Antihistamine

Medication Information

Indications and Usage

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

Antihistamine

Description

Fexofenadine HCl USP 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
Section 50566-9

Stop use and ask a doctor if

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

Section 50567-7

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)
Section 50569-3

Ask a doctor before use if you have

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

Section 50570-1

Do not use.

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

Section 51945-4

Section 53414-9

If pregnant or breast-feeding

ask a health professional before use.

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 (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 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.

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
Indications and Usage (34067-9)

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
Section 50566-9 (50566-9)

Stop use and ask a doctor if

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

Section 50567-7 (50567-7)

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)
Section 50569-3 (50569-3)

Ask a doctor before use if you have

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

Section 50570-1 (50570-1)

Do not use.

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding

ask a health professional before use.

Purpose (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 (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 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.

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: 2026-02-15T12:08:08.129280 · Updated: 2026-03-14T23:12:17.704012