ALLERGY RELIEF NON-DROWSY- fexofenadine hcl tablet, coated 
BJWC (Berkley & Jensen / BJ's)

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DRUG FACTS

Active ingredient (in each film-coated tablet)

Fexofenadine HCl USP 180 mg

Purpose

Antihistamine

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

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.

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).

Directions

adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

  • each tablet contains: sodium 8 mg
  • store between 20-25ºC (68-77ºF)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

anhydrous lactose,colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose,  lactose monohydrate, pregelatinized starch (maize), stearic acid,  polyethylene glycol, red iron oxide, titanium dioxide, and yellow iron oxide

Questions or comments?

call toll free 1-800-934-1204 Monday- Friday 9AM- 5PM EST

Principal Display Panel

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

Original Prescription Strength

NON-DROWSY

ALLERGY RELIEF

FEXOFENADINE HYDROCHLORIDE 180 mg

ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF

  • RUNNY NOSE
  • SNEEZING
  • ITCHY, WATERY EYES
  • ITCHY NOSE OR THROAT

COATED 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: BJs Wholesale Club

25 Research Drive, Westborough, MA 01581

Product Label

Fexofenadine HCI USP 180 mg

BJs Non-Drowsy Allergy Relief

ALLERGY RELIEF  NON-DROWSY
fexofenadine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-504
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code SG;202
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68391-504-151 in 1 BOX03/31/201812/31/2023
1150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20450703/31/201812/31/2023
Labeler - BJWC (Berkley & Jensen / BJ's) (159082692)

Revised: 10/2021
Document Id: 84b2a0f0-2c81-4fdc-b611-1c7b72eb8355
Set id: 697d299d-abdb-4cae-bb8e-865fb605e82a
Version: 4
Effective Time: 20211007
 
BJWC (Berkley & Jensen / BJ's)