CLARITIN CHEWABLE COOL MINT FLAVOR- loratadine tablet, chewable

Claritin Chewable by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Loratadine

PURPOSE

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

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

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:

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

Indoor & Outdoor

Allergies

Cool Mint

Flavored

*When taken as directed.

See Drug Facts Panel.

8 Chewable Tablets

INGREDIENTS AND APPEARANCE

CLARITIN CHEWABLE  COOL MINT FLAVOR
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-4364
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)
ASPARTAME (UNII: Z0H242BBR1)
MANNITOL (UNII: 3OWL53L36A)
MENTHOL (UNII: L7T10EIP3A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	11mm
Flavor	MINT	Imprint Code	CA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-4364-1	3 in 1 CARTON	12/09/2019
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 11523-4364-2	1 in 1 CARTON	12/09/2019
2		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 11523-4364-3	1 in 1 CARTON	12/09/2019
3		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 11523-4364-5	8 in 1 CARTON	12/09/2019
4		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 11523-4364-6	1 in 1 CARTON	12/09/2019
5		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 11523-4364-7	1 in 1 POUCH	12/09/2019
6		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC: 11523-4364-4	7 in 1 CARTON	12/09/2019
7		8 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	12/09/2019

Labeler - Bayer HealthCare LLC. (112117283)