DailyMed - CLARITIN CHEWABLE COOL MINT FLAVOR- loratadine tablet, chewable

NDC Code(s): 11523-4364-1, 11523-4364-2, 11523-4364-3, 11523-4364-4, view more
11523-4364-5, 11523-4364-6, 11523-4364-7
Packager: Bayer HealthCare LLC.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: New Drug Application

Drug Label Information

Updated December 13, 2023

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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ACTIVE INGREDIENT
Active ingredient - Loratadine

Active ingredient

Loratadine
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PURPOSE
Purpose - Antihistamine

Purpose

Antihistamine
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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

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
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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 ...

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.

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Directions
Directions - • chew or crush tablets completely before swallowing - adults and children 6 years and overchew 1 tablet daily; not more than 1 tablet in 24 hours - children under 6 years of ageask ...

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

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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 ...

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)
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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 ...

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

Questions or comments?

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

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INGREDIENTS AND APPEARANCE

Product Information

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

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021891	12/09/2019

Labeler - Bayer HealthCare LLC. (112117283)

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Published Date (What is this?)	Version	Files
Dec 14, 2023	4 (current)	download
Nov 4, 2022	3	download
Dec 29, 2021	2	download
Dec 9, 2019	1	download

	RxCUI	RxNorm NAME	RxTTY
1	2265266	loratadine 10 MG Chewable Tablet	PSN
2	2265266	loratadine 10 MG Chewable Tablet	SCD
3	2265267	Claritin 10 MG Chewable Tablet	PSN
4	2265267	loratadine 10 MG Chewable Tablet [Claritin]	SBD
5	2265267	Claritin 10 MG Chewable Tablet	SY

Label: CLARITIN CHEWABLE COOL MINT FLAVOR- loratadine tablet, chewable

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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

	NDC
1	11523-4364-1
2	11523-4364-2
3	11523-4364-3
4	11523-4364-4
5	11523-4364-5
6	11523-4364-6
7	11523-4364-7

Label: CLARITIN CHEWABLE COOL MINT FLAVOR- loratadine tablet, chewable

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Find additional resources

Safety

Related Resources

More Info on this Drug

CLARITIN CHEWABLE COOL MINT FLAVOR- loratadine tablet, chewable

Number of versions: 4

CLARITIN CHEWABLE COOL MINT FLAVOR- loratadine tablet, chewable

CLARITIN CHEWABLE COOL MINT FLAVOR- loratadine tablet, chewable

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CLARITIN CHEWABLE COOL MINT FLAVOR- loratadine tablet, chewable

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.