CLARITIN- loratadine tablet 
Bayer HealthCare LLC.

----------

Clairtin - Project Fortify

Drug Facts

Active ingredient (in each tablet)

Loratadine, 10 mg USP

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

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

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use

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

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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

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

■ store at 20º -25º C (68º -77º F) (see USP Controlled Room Temperature)

Inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

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

Carton label 10 count tablets

Original Prescription Strength

Non-Drowsy*

Claritin®

loratadine tablets 10 mg/antihistamine

Indoor & Outdoor

Allergies

24

Hour

Relief of:

*When taken as directed.

See Drug Facts Panel

Carton label 10 count

CLARITIN 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0007
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code Claritin;10;458
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-0007-11 in 1 CARTON12/01/2020
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11523-0007-22 in 1 CARTON12/01/2020
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:11523-0007-330 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
4NDC:11523-0007-785 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
5NDC:11523-0007-440 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
6NDC:11523-0007-545 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
7NDC:11523-0007-82 in 1 CARTON07/30/2021
7115 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:11523-0007-960 in 1 BOTTLE; Type 0: Not a Combination Product03/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01965812/01/2020
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 5/2022
Document Id: de08d044-d572-48cd-e053-2a95a90a619f
Set id: acf2d393-53d7-062f-e053-2995a90a0d60
Version: 7
Effective Time: 20220502
 
Bayer HealthCare LLC.