12HR ALLERGY RELIEF- fexofenadine hydrochloride tablet 
CARDINAL HEALTH

----------

1191A-LEA-2021-0924

Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl 60 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 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 over

take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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

Other information

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0586-1

NON-DROWSY

12 HR Allergy Relief

Fexofenadine Hydrochloride Tablets, 60 mg

Antihistamine

Indoor/Outdoor Relief of:

Sneezing; Runny Nose; Itchy, Watery Eyes;

Itchy Nose or Throat

12 TABLETS

Actual Size

COMPARE TO ALLEGRA® 12 HOUR ALLERGY active ingredient*

100% Money Back Guarantee

image description

12HR ALLERGY RELIEF 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0586
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colororange ((PEACH)) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code G5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0586-11 in 1 CARTON09/24/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21107509/24/2021
Labeler - CARDINAL HEALTH (063997360)

Revised: 9/2021
Document Id: ccc271cc-6aa2-f753-e053-2995a90a1161
Set id: ea5d0e55-2191-4094-b082-24b317f95752
Version: 2
Effective Time: 20210924
 
CARDINAL HEALTH