CLARITIN- loratadine tablet, chewable

Claritin by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredients

Loratadine 5 mg

Purpose

Antihistamine

INDICATIONS & USAGE

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

Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

AS a doctor before use if you have

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 and ask a doctor if

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

PREGNANCY 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.

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 1.9 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 INGREDIENT

aspartame, carmine, citric acid, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

QUESTIONS

1-800-CLARITIN

WARNINGS

PRINCIPAL DISPLAY PANEL

ages

2 years®

and older

Children's

Claritin®

Chewables

loratadine 5 mg/antihistamine

Indoor & Outdoor

Allergies

*When taken as directed.

See Drug Facts Panel

Non-Drowsy*

24 Hour Relief of:

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

Bubblegum

Flavored

10

Chewable Tablets

INGREDIENTS AND APPEARANCE

CLARITIN 
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-4330
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
ASPARTAME (UNII: Z0H242BBR1)

Product Characteristics
Color	pink (Light to Medium Pink with a Slightly and/or Mottled Appearance)	Score	no score
Shape	ROUND (Round (Flat Faced Beveled Edge))	Size	10mm
Flavor	BUBBLE GUM	Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-4330-1	1 in 1 CARTON	09/25/2015
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 11523-4330-3	3 in 1 CARTON	09/25/2015
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 11523-4330-4	4 in 1 CARTON	09/25/2015
3		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	09/25/2015

Labeler - Bayer HealthCare LLC. (112117283)