Claritin: Package Insert and Label Information

CLARITIN- loratadine tablet, chewable
Bayer HealthCare LLC.

Active ingredient (in each tablet)

Loratadine 5 mg

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 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 over	chew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of age	chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

• phenylketonurics: contains phenylalanine 1.4 mg per tablet
• safety sealed: do not use if the individual blister unit imprinted with Children’s Claritin® is open or torn
• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate,stearic acid

Questions or comments?

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

Dist by: Bayer HealthCare LLC, Whippany, NJ 07981

Product of Ireland

PRINCIPAL DISPLAY PANEL

CLARITIN loratadine tablet, chewable

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-0104 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 5 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID SILICON DIOXIDE D&C RED NO. 27 FD&C BLUE NO. 2 ALUMINUM OXIDE MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE STEARIC ACID SODIUM STARCH GLYCOLATE TYPE A POTATO ASPARTAME

Product Characteristics Color purple (Light purple tablet with slightly mottled appearance) Score no score Shape ROUND Size 10mm Flavor GRAPE Imprint Code C Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:11523-0104-1 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (11523-0104-1) 2 NDC:11523-0104-2 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (11523-0104-2) 3 NDC:11523-0104-3 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK 3 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (11523-0104-3) 4 NDC:11523-0104-4 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK 4 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (11523-0104-4) 5 NDC:11523-0104-5 6 BLISTER PACK in 1 CARTON contains a BLISTER PACK 5 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (11523-0104-5)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210033 02/05/2023

Labeler — Bayer HealthCare LLC. (112117283)

Revised: 05/2023 Bayer HealthCare LLC.