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_Children_Grape_Tablet_40ct

CLARITIN
loratadine tablet, chewable

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
ASPARTAME (UNII: Z0H242BBR1)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11523-0104-1	1 in 1 CARTON	02/08/2023
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:11523-0104-2	2 in 1 CARTON	02/08/2023
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:11523-0104-3	3 in 1 CARTON	02/08/2023
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:11523-0104-4	4 in 1 CARTON	02/08/2023
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:11523-0104-5	6 in 1 CARTON	02/08/2023
5		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC:11523-0104-6	8 in 1 CARTON	02/05/2023
6		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

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

Labeler - Bayer HealthCare LLC. (112117283)

Children Claritin ® Chewables Perrigo