Fexofenadine Hydrochloride Tablets Usp, 180 Mg

Fexofenadine Hydrochloride Tablets Usp, 180 Mg
SPL v6
SPL
SPL Set ID 852c8ad2-fc7d-4728-b2c6-f64b960fe2ab
Route
ORAL
Published
Effective Date 2020-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Silicon Dioxide Hypromellose 2910 (6 Mpa.s) Light Mineral Oil Magnesium Stearate Microcrystalline Cellulose Polysorbate 80 Starch, Corn Ferric Oxide Red Ferric Oxide Yellow Sodium Starch Glycolate Type A Potato Talc Titanium Dioxide Polyethylene Glycol 6000

Identifiers & Packaging

Pill Appearance
Imprint: J;44 Shape: capsule Color: pink Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2011-04-14
Description

Fexofenadine hydrochloride USP, 180 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Fexofenadine hydrochloride USP, 180 mg

Use(s)

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Questions

call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418

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 printed foil inner seal on the bottle is torn or missing.
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
Active Ingredient(s)

Fexofenadine hydrochloride USP, 180 mg

Inactive Ingredients

Colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

Principal Display Panel

Fexofenadine Hydrochloride Tablets, USP 180 mg 30 ct Container Label

Fexofenadine Hydrochloride Tablets, USP 180 mg 30ct Carton Label

Fexofenadine Hydrochloride Tablets, USP 180 mg 2x30 ct Carton Label

Fexofenadine Hydrochloride Tablets, USP 180 mg 120 ct Container Label

Fexofenadine Hydrochloride Tablets, USP 180 mg 120 ct Carton Label

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.

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Or Pharmacist Before Use If

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

Structured Label Content

Use(s)

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Purpose

Antihistamine

Questions

call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418

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 printed foil inner seal on the bottle is torn or missing.
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
Active Ingredient(s) (Active ingredient(s))

Fexofenadine hydrochloride USP, 180 mg

Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

Principal Display Panel

Fexofenadine Hydrochloride Tablets, USP 180 mg 30 ct Container Label

Fexofenadine Hydrochloride Tablets, USP 180 mg 30ct Carton Label

Fexofenadine Hydrochloride Tablets, USP 180 mg 2x30 ct Carton Label

Fexofenadine Hydrochloride Tablets, USP 180 mg 120 ct Container Label

Fexofenadine Hydrochloride Tablets, USP 180 mg 120 ct Carton Label

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 A Doctor If (Stop use and ask a doctor if)

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

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

ask a health professional before use.

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:53.847117 · Updated: 2026-03-14T23:08:19.346855