CLARITIN CHEWABLE COOL MINT FLAVOR- loratadine tablet, chewable 
Bayer HealthCare LLC.

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Claritin 10mg Cool Mint Chewable (1613932)

Drug Facts

Active ingredient

Loratadine

Purpose

Antihistamine

Uses

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

Directions

• chew or crush tablets completely before swallowing

adults and children 6 years and overchew 1 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

Other information

• phenylketonurics: contains phenylalanine 3 mg per tablet

• 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)

Inactive ingredients

anhydrous citric acid;aspartame;fd&c blue no. 1--aluminum lake;magnesium

stearate;mannitol;menthol;microcrystalline cellulose;silicon dioxide;sodium starch glycolate type a corn;stearic acid

Questions or comments

Questions or comments?

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

Carton 8 count

New Cool Mint

10 mg Chewable

Non-Drowsy*

Claritin®

Chewables

loratadine chewable tablets

10 mg/antihistamine

24 Hour Relief of:

Indoor & Outdoor

Allergies

Cool Mint

Flavored

*When taken as directed.

See Drug Facts Panel.

8 Chewable Tablets

Carton label 8 count

CLARITIN CHEWABLE  COOL MINT FLAVOR
loratadine tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4364
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
MENTHOL (UNII: L7T10EIP3A)  
ASPARTAME (UNII: Z0H242BBR1)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize11mm
FlavorMINTImprint Code CA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-4364-13 in 1 CARTON12/09/2019
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11523-4364-21 in 1 CARTON12/09/2019
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:11523-4364-31 in 1 CARTON12/09/2019
34 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:11523-4364-58 in 1 CARTON12/09/2019
48 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:11523-4364-61 in 1 CARTON12/09/2019
58 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:11523-4364-71 in 1 POUCH12/09/2019
62 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:11523-4364-47 in 1 CARTON12/09/2019
78 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02189112/09/2019
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 12/2023
Document Id: 0c665726-d675-1d6f-e063-6294a90a71c3
Set id: 98b99bb9-d499-9ab4-e053-2a95a90a6ae6
Version: 4
Effective Time: 20231213
 
Bayer HealthCare LLC.