CLARITIN- loratadine tablet

Claritin by

Drug Labeling and Warnings

Claritin by is a Otc medication manufactured, distributed, or labeled by R J General Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLARITIN ®

• Active ingredients (in each tablet):

  Purpose

• Loratadine 10 mg:

  Antihistamine

USE

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

Stop use and ask doctor ifan allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,ask 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
• consumer with liver or kidney disease: ask a doctor

Other information

• Safety sealed: do not use if the individual blister unit imprinted with Claritin ® is open or torn
• Store between 20 o to 25 o C(68 oto 77 oF)
• Protect from excessive moisture

Inactive ingredients

Corn starch, lactose monohydrate, magnesium stearate

Questions and Comments?

1-800-CLARITIN(1-800-252-7484)or www.claritin.com

Dist. by: Bayer HealthCare LLC

Whippany, NJ 07981

Product of India

Do not use if pouch is torn or broken.

Repackaged and distributed by:

RJ General

2024 Northwest Drive

Cincinnati OH 45231

PURPOSE

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

INDICATIONS & USAGE

PRINCIPAL DISPLAY PANEL - 25 Tablet Pouch Carton

Non-Drowsy*

Claritin ®

loratadine tablets 10 mg/ antihistamine

Indoor & Outdoor Allergies

Relief of:

• runny nose
• itchy, watery eyes
• sneezing
• itching of the throat or nose 

INGREDIENTS AND APPEARANCE

CLARITIN 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70264-030(NDC:11523-6655)
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)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	458;Claritin;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70264-030-01	25 in 1 CARTON	12/26/2022
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019658	03/01/2021

Labeler - R J General Corporation (122542830)

Establishment
Name	Address	ID/FEI	Business Operations
R J General Corporation		122542830	repack(70264-030)