24HR ALLERGY RELIEF- fexofenadine hydrochloride tablet 
LEADER/ Cardinal Health 110, Inc.

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Fexofenadine HCl Tablets USP

Active ingredient (in each tablet)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Uses

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



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 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.

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 agedo not use
adults 65 years of age  and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titantium dioxide

Questions?

call 1-888-375-3784

Package Label - 30 Count Carton

NDC 70000-0361-2 LEADER

NON-DROWSY

Original Prescription Strength

24HR Allergy Relief
Fexofenadine Hydrochloride
Tablets USP, 180 mg l Antihistamine

Indoor and Outdoor Allergies

24 Hour
Relief of
Sneezing, Runny Noise, Itchy Nose or Throat
and Itchy, Watery Eyes

COMPARE TO ALLEGRA®
ALLERGY 24HR
active ingredient*

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30 TABLETS

Carton

Package Label - 30 Count Bottle

NDC 70000-0361-2 LEADER

NON-DROWSY

Original Prescription Strength

24HR Allergy Relief
Fexofenadine Hydrochloride
Tablets USP, 180 mg l Antihistamine

Indoor and Outdoor Allergies

24 Hour

30 TABLETS

Bottle


24HR ALLERGY RELIEF 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0361(NDC:55111-784)
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)  
magnesium stearate (UNII: 70097M6I30)  
mannitol (UNII: 3OWL53L36A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
polyethylene glycol 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize7mm
FlavorImprint Code 194;R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0361-21 in 1 CARTON04/27/2018
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70000-0361-13 in 1 CARTON04/27/2018
25 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:70000-0361-31 in 1 CARTON04/27/2018
370 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:70000-0361-41 in 1 CARTON04/27/2018
490 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:70000-0361-51 in 1 CARTON04/23/2020
5180 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07650204/27/2018
Labeler - LEADER/ Cardinal Health 110, Inc. (063997360)

Revised: 6/2021
Document Id: 069eb55b-d2f0-1a2e-5ad8-ef68f7501c26
Set id: 8917abc8-d391-89d1-ef3b-19e1702bc83d
Version: 5
Effective Time: 20210615
 
LEADER/ Cardinal Health 110, Inc.