ALLERGY RELIEF- fexofenadine hcl tablet 
PLD Acquisitions LLC DBA Avéma Pharma Solutions

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DRUG FACTS

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 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

colloidal silicon dioxide, hypromellose, light liquid paraffin magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide

Questions or comments?


Principal Display Panel

Compare to the active ingredient in Allegra® Allergy 24 Hour

ALLERGY RELIEF

Fexofenadine HCL USP180 mg

Antihistamine

24 Hour Relief of:

Indoor and outdoor allergy relief

Caplets**

(**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.


Product Label

Fexofenadine HCL USP 180 mg

Allergy Relief

ALLERGY RELIEF 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0664
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)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code J;44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63548-0664-5500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20409710/01/2019
Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 2/2023
Document Id: df845ee9-b17a-484f-be90-1918450c6b75
Set id: 9f1f292d-6d5f-4600-ad27-323e498ddecb
Version: 2
Effective Time: 20230209
 
PLD Acquisitions LLC DBA Avéma Pharma Solutions