Fexofenadine HCl by Chain Drug Marketing Association FEXOFENADINE HCL tablet

Fexofenadine HCl by

Drug Labeling and Warnings

Fexofenadine HCl by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 248-449-9300

Package/Label Principal Display Panel

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

ORIGINAL PRESCRIPTION STRENGTH

Fexofenadine HCl tablets 180 mg/ Antihistamine

INDOOR & OUTDOOR ALLERGIES

NON-DROWSY

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. DO NOT USE IF CARTON IS OPEN OR IF INDIVIDUAL BLISTER IS TORN OR OPEN.

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

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

Product Label

 

Fexofenadine Hcl 180 mg 15 count

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL 
fexofenadine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-024
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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 GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONES (UNII: FZ989GH94E)
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-024-15	1 in 1 CARTON
1		15 in 1 BLISTER PACK
2	NDC: 63868-024-30	1 in 1 BOX
2		30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079112	08/27/2012

Labeler - Chain Drug Marketing Association (011920774)