claritin ®

Drug Facts

Composition & Product

Active Ingredients

loratadine (5 mg)

Inactive Ingredients

anhydrous citric acid gelatin mannitol

Identifiers & Packaging

Pill Appearance

Imprint: C5 Shape: round Color: white Size: 12 mm Score: 1

Marketing Status

nda active Since 2006-12-12

Medication Information

Active Ingredient

Loratadine 5 mg

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

Purpose

Antihistamine

Directions

place 1 tablet on tongue; tablet disintegrates, with or without water

adults and children 6 years and over	1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other Information

safety sealed: do not use if the individual blister unit imprinted with Claritin® RediTabs® is open or torn
store between 20° to 25°C (68° to 77°F)
use tablet immediately after opening individual blister
complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration

Inactive Ingredients

anhydrous citric acid, gelatin, mannitol, mint flavor

Description

Drug Facts

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 53414-9

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

Questions Or Comments?

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

Principal Display Panel 10 Tablet Carton

NDC 11523-7202-3

Non-Drowsy*

Claritin ^®

RediTabs ^®

loratadine 5 mg/antihistamine

Indoor & Outdoor

Allergies

*When taken as directed. See Drug Facts Panel.

12

Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

or Nose

No Water Needed

Melts in Your Mouth

10

ORALLY

DISINTEGRATING TABLETS

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Loratadine 5 mg

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

Purpose

Antihistamine

Directions

place 1 tablet on tongue; tablet disintegrates, with or without water

adults and children 6 years and over	1 tablet every 12 hours; not more than 2 tablets 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)

safety sealed: do not use if the individual blister unit imprinted with Claritin® RediTabs® is open or torn
store between 20° to 25°C (68° to 77°F)
use tablet immediately after opening individual blister
complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, gelatin, mannitol, mint flavor

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 53414-9 (53414-9)

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

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel 10 Tablet Carton (PRINCIPAL DISPLAY PANEL - 10 Tablet Carton)

NDC 11523-7202-3

Non-Drowsy*

Claritin ^®

RediTabs ^®

loratadine 5 mg/antihistamine

Indoor & Outdoor

Allergies

*When taken as directed. See Drug Facts Panel.

12

Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

or Nose

No Water Needed

Melts in Your Mouth

10

ORALLY

DISINTEGRATING TABLETS

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antihistamine", "Directions": "place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "Other information": "safety sealed: do not use if the individual blister unit imprinted with Claritin® RediTabs® is open or torn store between 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration", "Inactive ingredients": "anhydrous citric acid, gelatin, mannitol, mint flavor", "Questions or comments?": "1-800-CLARITIN (1-800-252-7484) or www.claritin.com", "Active ingredient (in each tablet)": "Loratadine 5 mg", "PRINCIPAL DISPLAY PANEL - 10 Tablet Carton": "NDC 11523-7202-3 Non-Drowsy* Claritin ® RediTabs ® loratadine 5 mg /antihistamine Indoor & Outdoor Allergies *When taken as directed. See Drug Facts Panel. 12 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose No Water Needed Melts in Your Mouth 10 ORALLY DISINTEGRATING TABLETS"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information