ALLERGY RELIEF- fexofenadine hcl tablet 
P & L Development, LLC

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DRUG FACTS

Active ingredient (in each film-coated 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.

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 tablet 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

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate pregelatinized starch (maize),stearic acid, opady pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide, titanium dioxide, and yellow iron oxide

Questions or comments?

call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Compare to the active ingredient in Allegra® Allergy 24 hour*

ORIGINAL PRESCRIPTION STRENGTH

allergy relief

Fexofenadine HCl 180 mg

Antihistamine

for Indoor and outdoor allergies

non-drowsy

coated caplets**

(**capsules-shaped tablets)

24 Hour Relief of:

*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 hour

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Product Label

Fexofenadine HCl USP 180 mg

READYinCASE Allergy Relief

ALLERGY RELIEF 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-504
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)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code SG;202
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-504-033 in 1 CARTON03/31/201603/31/2025
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:59726-504-3030 in 1 CARTON03/31/201603/31/2025
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:59726-504-121 in 1 BOX03/31/201603/31/2025
3120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911203/31/201603/31/2025
Labeler - P & L Development, LLC (800014821)

Revised: 6/2023
Document Id: 522a2c28-06ff-4216-9eec-1ba076cf46fb
Set id: a9b4fbac-324a-460e-91d6-14e16b307ad4
Version: 7
Effective Time: 20230607
 
P & L Development, LLC