Major Pharmaceuticals

Fexofenadine Hydrochloride by

Drug Labeling and Warnings

Fexofenadine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Denton Pharma, Inc. DBA Northwind Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FEXOFENADINE HYDROCHLORIDE- fexofenadine hcl tablet 
Denton Pharma, Inc. DBA Northwind 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:

  • 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 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

  • each tablet contain: sodium 8 mg
  • store between 20 to 25°C (68 to 77°F)
  • 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, 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:

  • sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy nose or throat

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

NDC: 70934-629-90

Label

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70934-629(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: 70934-629-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/18/202203/31/2025
2NDC: 70934-629-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/11/202201/31/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20450708/11/202203/31/2025
Labeler - Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Registrant - Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Establishment
NameAddressID/FEIBusiness Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals080355546repack(70934-629)

Revised: 1/2023
 
Denton Ph

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