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 • 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.

Directions

adults and Children 12 years and older	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 diseases	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° to 25° C (68° to 77° F)
• protect from excessive moisture

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate

Questions or comments?

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

Package Labeling:

Claritin

CLARITIN
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67751-153(NDC:11523-7160)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	458;Claritin10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67751-153-01	1 in 1 CARTON	09/17/2016
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019658	09/17/2016

Labeler - Navajo Manufacturing Company Inc. (091917799)

Name	Address	ID/FEI	Business Operations
Establishment
Navajo Manufacturing Company Inc.		136941411	relabel(67751-153) , repack(67751-153)