FEXOFENADINE HYDROCHLORIDE- fexofenadine hcl tablet 
Major Pharmaceuticals

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Major Pharmaceuticals

Active ingredient (in each film-coated tablet)

Fexofenadine HCL 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 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 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

Other information

Inactive ingredients

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

Questions or comments?

Call: 1-800-616-2471

Principal Display Panel

 COMPARE TO the active ingredient in ALLEGRA® ALLERGY 24 HOUR*

FEXOFENADINE HYDROCHLORIDE USP 180 mg

 Antihistamine

ALLERGY RELIEF

24-HOUR Relief of:

Indoor and Outdoor

Allergy Relief

Non-Drowsy

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

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

Product Label

Fexofenadine HCL USP 180 mg

MAJOR PHARMACEUTICALS Allergy Relief

 

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7050
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)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code SG;202
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7050-40500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/29/2019
2NDC:0904-7050-60100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20450711/29/2019
Labeler - Major Pharmaceuticals (191427277)

Revised: 12/2022
Document Id: 261b707f-0b54-411e-9c75-e3555f88668b
Set id: c34cda59-8a63-48ab-a19d-c06a1878f5da
Version: 4
Effective Time: 20221209
 
Major Pharmaceuticals