Claritin 10mg Cool Mint Chewable (1613932)

SPL v5

SPL

SPL Set ID 98b99bb9-d499-9ab4-e053-2a95a90a6ae6

Route

ORAL

Published

Effective Date 2019-12-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Sodium Starch Glycolate Type A Corn Stearic Acid Magnesium Stearate Silicon Dioxide Fd&c Blue No. 1--aluminum Lake Menthol Anhydrous Citric Acid Aspartame Mannitol Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

Imprint: CA Shape: round Color: blue Size: 11 mm Score: 1

Marketing Status

NDA Active Since 2019-12-09

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different

dose.

Section 50570-1

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

Section 51727-6

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient

Loratadine

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

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

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)

Questions Or Comments

Questions or comments?

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

Structured Label Content

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 and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different

dose.

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient

Loratadine

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

Carton 8 Count (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

Other Information (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)

Questions Or Comments (Questions or comments)

Questions or comments?

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "34071-1": "Warnings", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50567-7": "When using this product do not take more than directed. Taking more than directed may cause drowsiness.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "51727-6": "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", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Antihistamine", "55106-9": "Active ingredient Loratadine", "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", "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", "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)", "Questions or comments": "Questions or comments? 1-800-CLARITIN (1-800-252-7484) or www.claritin.com"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:30.044656 · Updated: 2026-03-14T23:11:02.639613