Berkley and Jensen Allergy Relief description, usages, side effects, indications, overdosage, supplying and lots more!

Berkley and Jensen Allergy Relief

BJWC

  • 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
BJWC Allergy Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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. (1-800-222-1222)

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

  • •do not use if printed foil under cap is broken or missing
  • •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

Questions or comments?

1-800-934-1204

Package/Label Principal Display Panel

INDOOR/OUTDOOR ALLERGIES

ORIGINAL PRESCRIPTION STRENGTH

ALLERGY RELIEF

FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg

ANTIHISTAMOINE

RELIEF OF:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Nose or Throat

NON-DROWSY

24 HOUR

Compare to the active ingredient of Allegra® Allergy

ACTUAL SIZE

120 TABLETS

180 mg EACH

Berkley and Jensen Allergy Relief

fexofenadine hcl TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68391-571
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
FERROSOFERRIC OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POVIDONES
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
ORANGE (peach) 12 mm 93;7253 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 120 in 1 BOTTLE
2 NDC:68391-571-76 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076447 2011-08-11


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Be sure to consult your doctor before taking any medication!
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