Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID a976ad95-33d2-49f5-bad5-e980bf764879
Route
ORAL
Published
Effective Date 2025-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Hypromelloses Ferric Oxide Red Ferric Oxide Yellow Lactose Monohydrate Polyethylene Glycol, Unspecified Titanium Dioxide Ferrosoferric Oxide Starch, Corn Microcrystalline Cellulose Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: G6 Shape: capsule Color: pink Size: 17 mm Score: 1
Marketing Status
ANDA Completed Since 2021-08-20 Until 2026-12-30

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
  • itchy, watery eyes
  • sneezing
  • 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
READYinCASE Allergy Relief
Other Information
  • store between 20-25ºC (68-77ºF)
  • protect from excessive moisture



Inactive Ingredients

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

Questions Or Comments?

call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Allegra® Allergy 24 Hour*

allergy relief

fexofenadine HCl tablets USP, 180 mg

antihistamine

for indoor and outdoor allergies

non-drowsy

24 hour relief of

  • runny nose
  • sneezing,
  • itchy, watery eyes
  • itchy nose or throat
  • for indoor & outdoor allergies
  • non-drowsy

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.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

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 (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have

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

Active Ingredient (in Each  tablet)

Fexofenadine HCl USP, 180 mg


Structured Label Content

Uses

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

  • runny nose
  • itchy, watery eyes
  • sneezing
  • 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
READYinCASE Allergy Relief
Other Information (Other information)
  • store between 20-25ºC (68-77ºF)
  • protect from excessive moisture



Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Allegra® Allergy 24 Hour*

allergy relief

fexofenadine HCl tablets USP, 180 mg

antihistamine

for indoor and outdoor allergies

non-drowsy

24 hour relief of

  • runny nose
  • sneezing,
  • itchy, watery eyes
  • itchy nose or throat
  • for indoor & outdoor allergies
  • non-drowsy

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.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

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 (1-800-222-1222) right away.

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.

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

Fexofenadine HCl USP, 180 mg


Advanced Ingredient Data


Raw Label Data

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