CLARITIN- loratadine tablet, chewable

Claritin by

Drug Labeling and Warnings

Claritin by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC., Patheon Manufacturing Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Dist by: Bayer HealthCare LLC, Whippany, NJ 07981

Product of Ireland

PRINCIPAL DISPLAY PANEL - 10 Chewable Tablet Blister Pack Carton

NDC: 11523-4328-1

ages

2 years

and older

Children's

Claritin®

Allergy

loratadine 5 mg/antihistamine

Indoor & Outdoor

Allergies

Non-Drowsy*

24 Hour Relief of:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

10 CHEWABLE TABLETS

Grape

Flavored

Chewables

*When taken as directed. See Drug Facts Panel.

INGREDIENTS AND APPEARANCE

CLARITIN 
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-4328
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
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)

Product Characteristics
Color	purple (light to medium purple with a slightly speckled and/or mottled appearance)	Score	no score
Shape	ROUND (flat faced beveled edge)	Size	10mm
Flavor	GRAPE	Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-4328-1	1 in 1 CARTON	08/23/2006
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 11523-4328-2	2 in 1 CARTON	08/23/2006
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 11523-4328-3	3 in 1 CARTON	08/23/2006
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 11523-4328-5	5 in 1 CARTON	08/23/2006
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 11523-4328-4	1 in 1 POUCH	08/23/2006
5		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 11523-4328-7	2.5 in 1 PACKAGE, COMBINATION	08/23/2006
6		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC: 11523-4328-9	4 in 1 CARTON	08/23/2006
7		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
8	NDC: 11523-4328-6	50 in 1 BOX	08/23/2006
8		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021891	08/23/2006

CLARITIN 
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-4331
Route of Administration	ORAL

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

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

Product Characteristics
Color	purple (Light to medium purple with a slightly speckled and/or mottled appearance)	Score	no score
Shape	ROUND (Flat Faced Beveled Edge)	Size	10mm
Flavor	GRAPE	Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-4331-1	4 in 1 CARTON	08/23/2006
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 11523-4331-2	6 in 1 CARTON	09/06/2019
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021891	08/23/2006

Labeler - Bayer HealthCare LLC. (112117283)