Fexofenadine HCl description, usages, side effects, indications, overdosage, supplying and lots more!

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Fexofenadine HCl

Chain Drug Marketing Association

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Fexofenadine HCl 180 mg

Purpose

Antihistamine

Fexofenadine HCl 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

Fexofenadine HCl 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

Fexofenadine Hcl 180 mg 15 count

Fexofenadine HCl

Fexofenadine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63868-024
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE 180 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
ferric oxide red
FERRIC OXIDE YELLOW
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POVIDONES
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE (light peach) 17 mm w987 CAPSULE

Packaging

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

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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