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Name:Berkley And Jensen Loratadinenon Drowsy
Manufacturer:Bjwc
Category:Over-the-counter (OTC) Marketed Drugs


BJWC Loratadine Tablets, 10 mg Drug Facts

BERKLEY AND JENSEN LORATADINE NON DROWSY - loratadine tablet 
BJWC

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BJWC Loratadine Tablets, 10 mg Drug Facts

Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • 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

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

When using this product

do not take more than directed. Taking more than directed may cause drowsiness.

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 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

Other information

  • do not use if blister unit is broken or torn {Blister Only}
  • do not use if printed foil under cap is broken or missing {Bottle Only}
  • store at 20°-25°C (68°-77°F)
  • protect from excessive moisture {Blister Only}

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-934-1204

Principal Display Panel

Compare to the active ingredient in Claritin®

Original Prescription Strength

Loratadine

Tablets, 10 mg/Antihistamine

Non-Drowsy**

Indoor & Outdoor Allergies

For 24 Hour Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat or Nose

24 Hour

Allergy

**When taken as directed. See Drug Facts Panel.

Actual Size

Loratadine Tablets, 10 mg Carton Image #1

Loratadine Tablets, 10 mg Carton Image #1

Loratadine Tablets, 10 mg Carton Image #2

Loratadine Tablets, 10 mg Carton Image #2


BERKLEY AND JENSEN LORATADINE  NON DROWSY
loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-612
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
POVIDONE  
STARCH, CORN  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 8mm
Flavor Imprint Code L612
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68391-612-87 1 BOTTLE ( BOTTLE) in 1 PACKAGE contains a BOTTLE
1 300 TABLET ( TABLET) in 1 BOTTLE This package is contained within the PACKAGE (68391-612-87)
2 NDC:68391-612-46 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
2 10 TABLET ( TABLET) in 1 BOTTLE This package is contained within the CARTON (68391-612-46)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076301 04/17/2009

Labeler - BJWC (159082692)

Revised: 09/2009 BJWC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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