CLARITIN- loratadine tablet 
Navajo Manufacturing Company

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Claritin

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:

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 over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate

Questions or Comments?

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

Principle Display Panel - 12 Pouch Dispensit

Principle Display Panel - 12 Pouch Dispensit

CLARITIN 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-153(NDC:11523-7160)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 458;Claritin10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67751-153-0212 in 1 TRAY12/04/2017
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01965812/04/2017
Labeler - Navajo Manufacturing Company (091917799)
Establishment
NameAddressID/FEIBusiness Operations
Navajo Manufacturing Company Inc.136941411relabel(67751-153) , repack(67751-153)

Revised: 11/2019
Document Id: 9689b2af-9d48-95a7-e053-2a95a90ac0d0
Set id: 60a5dc14-3f74-8414-e053-2991aa0ad34a
Version: 2
Effective Time: 20191104
 
Navajo Manufacturing Company