Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 9f1f292d-6d5f-4600-ad27-323e498ddecb
Route
ORAL
Published
Effective Date 2023-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Silicon Dioxide Light Mineral Oil Hypromelloses Ferric Oxide Red Ferric Oxide Yellow Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Polysorbate 80 Talc Titanium Dioxide Starch, Corn Sodium Starch Glycolate Type A Corn

Identifiers & Packaging

Pill Appearance
Imprint: J;44 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2019-10-01
Description

Fexofenadine HCL USP 180 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCL USP 180 mg

Uses

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
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.

Product Label
Allergy Relief
Other Information
  • Tamper Evident: do not use if printed safety seal under cap is broken or missing
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture
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, yellow iron oxide

Questions Or Comments?



Principal Display Panel

Compare to the active ingredient in Allegra® Allergy 24 Hour

ALLERGY RELIEF

Fexofenadine HCL USP180 mg

Antihistamine

24 Hour Relief of:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy nose or throat

Indoor and outdoor allergy relief

Caplets**

(**Capsule-shaped tablets)

*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 hour

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.



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.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredient (in Each Tablet)

Fexofenadine HCL USP 180 mg

Ask A Doctor Before Use If You Have

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

Structured Label Content

Uses

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

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.

Product Label
Allergy Relief
Other Information (Other information)
  • Tamper Evident: do not use if printed safety seal under cap is broken or missing
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture
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, yellow iron oxide

Questions Or Comments? (Questions or comments?)



Principal Display Panel

Compare to the active ingredient in Allegra® Allergy 24 Hour

ALLERGY RELIEF

Fexofenadine HCL USP180 mg

Antihistamine

24 Hour Relief of:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy nose or throat

Indoor and outdoor allergy relief

Caplets**

(**Capsule-shaped tablets)

*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 hour

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.



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.

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

ask a health professional before use.

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 (1-800-222-1222).

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Fexofenadine HCL USP 180 mg

Ask A Doctor Before Use If You Have (Ask a doctor 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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:31.902498 · Updated: 2026-03-14T23:01:00.090870