24 HOUR ALLERGY- fexofenadine hcl tablet
LIVE BETTER (The Great Atlantic & Pacific Tea Company)

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DRUG FACTS

Active ingredient (in each 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.

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

store at 20°-25°C (68°-77°F)
protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone k-30, talc, titanium dioxide.

Questions or comments?

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

Package/Label Principal Display Panel

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

ORIGINAL PRESCRIPTION STRENGTH

24 HOUR ALLERGY

Fexofenadine HCl tablets, USP

Indoor and outdoor allergies

180 mg/ Antihistamine

24 Hour Relief of:

sneezing
runny nose
itchy, watery eyes
itchy nose or throat

*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.

SAFETY SEALED: DO NOT USE IF CARTON IS OPEN OR IF INNER SEAL IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS MISSING OR TORN

Product Label

Fexofenadine HCl 180 mg tablet

24 HOUR ALLERGY
fexofenadine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53187-189
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Ingredient Name	Strength
Inactive Ingredients
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (light peach)	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	W987
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53187-189-30	1 in 1 BOX	03/20/2013	12/01/2017
1		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079112	03/20/2013	12/01/2017

Labeler - LIVE BETTER (The Great Atlantic & Pacific Tea Company) (001367366)

Registrant - P & L Development, LLC (079765031)

Revised: 4/2024

Document Id: 00ca3b61-a746-4996-821d-c8eda9e7994f

Set id: 9c83780f-08c0-459e-98f7-147762eb4c21

Version: 2

Effective Time: 20240410

LIVE BETTER (The Great Atlantic & Pacific Tea Company)