FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet 
MAJOR PHARMACEUTICALS

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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

MAJOR

COMPARE TO active ingredient of
ALLEGRA® ALLERGY 24 HOUR TABLETS*

NDC 0904-6711-46

Original Prescription Strength

FEXOFENADINE
HYDROCHLORIDE Tablets USP, 180 mg
Antihistamine

ALLERGY

Relief of:

Non-Drowsy

Indoor & Outdoor
Allergies

24
HOUR

30 TABLETS
180 mg EACH

Carton


Package Label - 30 Count Bottle

MAJOR NDC 0904-6711-46

Original Prescription Strength

FEXOFENADINE
HYDROCHLORIDE
Tablets USP, 180 mg / Antihistamine

ALLERGY

Indoor & Outdoor Allergies

Non-Drowsy

24
HOUR

30 TABLETS
180 mg EACH

Bottle

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6711(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:0904-6711-461 in 1 CARTON04/27/2018
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0904-6711-522 in 1 CARTON04/27/2018
230 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0904-6711-103 in 1 CARTON04/27/2018
35 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0904-6711-891 in 1 CARTON04/27/2018
490 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0904-6711-921 in 1 CARTON04/27/2018
5150 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 - MAJOR PHARMACEUTICALS (191427277)

Revised: 3/2018
Document Id: f895b568-70fc-b5d0-f60b-eba35903c2e5
Set id: 0a6da401-a8a3-5d0b-f37e-c220838f7e49
Version: 2
Effective Time: 20180306
 
MAJOR PHARMACEUTICALS