Available Formats

• Active ingredient (in each tablet)

  Fexofenadine HCl 180 mg

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• Purpose

  Antihistamine

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• 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

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• 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.

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• 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

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• Other information

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

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• 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.

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• Questions or comments?

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

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• Package/Label Principal Display Panel

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

  ORIGINAL PRESCRIPTION STRENGTH

  NON-DROWSY

  Fexofenadine HCl tablets, USP 180 mg

  Antihistamine

  ALLERGY

  Indoor and outdoor allergies

  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

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• Product Label

  

  Fexofenadine HCl 180 mg

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• INGREDIENTS AND APPEARANCE

  FEXOFENADINE HCL  fexofenadine hcl tablet

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-189(NDC:55648-987) 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 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:63941-189-30 1 in 1 BOX 1 30 in 1 BOTTLE 2 NDC:63941-189-60 1 in 1 BOX 2 60 in 1 BOTTLE

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079112 06/04/2012

  Labeler - Valu Merchandisers Company (Best Choice) (868703513)

  Registrant - P and L Development of New York Corporation (800014821)

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