BERKLEY AND JENSEN ALLERGY RELIEF- loratadine tablet

Berkley and Jensen Allergy Relief by

Drug Labeling and Warnings

Berkley and Jensen Allergy Relief by is a Otc medication manufactured, distributed, or labeled by BJWC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• 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

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. (1-800-222-1222)

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 printed foil under cap is broken or missing
• store between 20° to 25°C (68° to 77°F)

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

24 HOUR – NON-DROWSY*

ALLERGY RELIEF

LORATADINE TABLETS, 10 mg

ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF:

SNEEZING

RUNNY NOSE

ITCHY, WATERY EYES

ITCHY THROAT OR NOSE

ACTUAL SIZE

100% MONEY BACK GUARANTEE

365 TABLETS

*When taken as directed.

See Drug Facts Panel.

INGREDIENTS AND APPEARANCE

BERKLEY AND JENSEN ALLERGY RELIEF 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68391-314
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	L612
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68391-314-87	1 in 1 PACKAGE	04/17/2009	08/01/2015
1		300 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68391-314-88	1 in 1 PACKAGE	09/09/2011
2		365 in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - BJWC (159082692)