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

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DRUG FACTS

Active ingredient (in each tablet)

Fexofenadine HCl USP 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 overtake one 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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, hypromellose, light liquid paraffin,magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide, and yellow iron oxide

Questions or comments?

Principal Display Panel

*Compare to the active ingredient in Allegra® Allergy 12 hour

Allergy Relief

Fexofenadine HCL USP 180 mg

 Antihistamine

12 HOUR RELIEF OF:

Caplets**

(**Capsule-shaped Tablets)

*This product is not manufactured or distributed by Chattem, Inc., distributor of Allegra® Allergy 12 hour.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN MISSING.

Product Label

Fexofenadine HCL USP 60 mg

Allergy Relief

ALLERGY RELIEF 
fexofenadine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0663
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
TALC (UNII: 7SEV7J4R1U)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code J;43
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63548-0663-5500 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: 7/2019
Document Id: 511d285e-6e71-42e2-9260-cbf9182f9eb6
Set id: 0c83f650-f2bf-4c5b-a1e3-7c40cd9c4c6f
Version: 2
Effective Time: 20190716
 
PLD Acquisitions LLC DBA Avéma Pharma Solutions