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

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Fexofenadine Hydrochloride

Major Pharmaceuticals




FULL PRESCRIBING INFORMATION

Fexofenadine HCl 180 mg

Antihistamine

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

if you have ever had an allergic reaction to this product or any of its ingredients.

kidney disease. Your doctor should determine if you need a different dose.

  • 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)

an allergic reaction to this product occurs. Seek medical help right away.

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

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

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

Call: 1-800-616-2471

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

ORIGINAL PRESCRIPTION STRENGTH

FEXOFENADINE HYDROCHLORIDE Tablets 180 mg/ antihistamine

ALLERGY RELIEF 24 HOUR

NON-DROWSY

RELIEF OF:

sneezing

runny nose

itchy, watery eyes

itchy nose or throat

180 mg EACH

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

SAFETY SEALED: DO NOT USE IF CARTON IS OPEN OR IF INNER SEAL IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS MISSING OR TORN. (For Bottle configuration only)

DO NOT USE IF CARTON IS OPEN OR IF INDIVIDUAL BLISTER UNIT IS TORN OR OPEN ( For Blister configuration only)

Fexofenadine Hydrochloride

Major Fexofenadine HCl 180 mg
 

Fexofenadine Hydrochloride

Fexofenadine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-6311
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
povidone
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE ((Peach)) 7 mm W987 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-6311-18 120 in 1 BOTTLE, PLASTIC
2 NDC:0904-6311-46 30 in 1 BOTTLE, PLASTIC
3 NDC:0904-6311-48 15 in 1 BLISTER PACK
4 NDC:0904-6311-52 60 in 1 BOTTLE, PLASTIC
5 NDC:0904-6311-89 90 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079112 2012-09-04


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