FEX-ALLERGY RELIEF- fexofenadine hcl tablet 
Pioneer Life Sciences, LLC

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Fex-Allergy relief

Active Ingredient

Fexofenadine hydrochloride USP, 180 mg

Purpose

Antihistamine

Uses:

Do not use:

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

WHEN USING THIS PRODUCT

ASK A DOCTOR BEFORE USE IF

Kidney disease. Your doctor should determine if you need a different dose.

STOP USE AND ASK A DOCTOR IF

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

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 overTake one 180 mg tablet with water once a day; do not take more than 1 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, corn starch,croscarmellose sodium, magnesium stearate,mannitol and microcrystalline cellulose, opadry pink 03B54504 containing FD and C red No.40, iron oxide black,hypromellose,polyethylene glycol, titanium dioxide.

QUESTIONS OR COMMENTS?

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

Keep out of reach of children.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

PRINCIPAL DISPLAY PANEL

Label

FEX-ALLERGY RELIEF 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-061
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
MANNITOL (UNII: 3OWL53L36A)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code J;44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72090-061-9090 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20409709/21/2020
Labeler - Pioneer Life Sciences, LLC (014092742)

Revised: 9/2020
Document Id: b078c242-b8b6-51a0-e053-2a95a90a6b06
Set id: b078c242-b8b5-51a0-e053-2a95a90a6b06
Version: 1
Effective Time: 20200929
 
Pioneer Life Sciences, LLC