aller ease description, usages, side effects, indications, overdosage, supplying and lots more!

aller ease

Meijer Distribution Inc

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Meijer Distribution, Inc. Aller-Ease Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Fexofenadine HCl 60 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. (1-800-222-1222)

Directions

adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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

  • do not use if blister unit is broken or torn
  • store at 20°-25°C (68°-77°F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 3

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

1-800-719-9260

Package/Label Principal Display Panel

Compare to Allegra® Allergy active ingredient

Allergy

Aller-Ease

Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine

Original Prescription Strength

Non-Drowsy

Actual Size

Relief of:

Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Nose or Throat

12 Hour

Indoor & Outdoor Allergies

60 mg Each

Package/Label Principal Display Panel
Aller-Ease Carton Image 1 Aller-Ease Carton Image 2

aller ease

Fexofenadine HCl TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41250-425
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE 60 mg

Inactive Ingredients

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

Product Characteristics

Color Size Imprint Code Shape
ORANGE (Peach) 8 mm 93;7252 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BLISTER PACK
2 NDC:41250-425-53 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076447 2011-08-24


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Be sure to consult your doctor before taking any medication!
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