Claritin ®

Claritin ®
SPL v12
SPL
SPL Set ID b681ea25-d00b-4c8a-8054-cc6f983ce337
Route
ORAL
Published
Effective Date 2014-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Mannitol Anhydrous Citric Acid Gelatin

Identifiers & Packaging

Pill Appearance
Imprint: C10 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
NDA Active Since 2002-11-27

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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 53414-9

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

Directions
  • place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children 6 years and over 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
  • 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 10 mg

Principal Display Panel 10 Tablet Carton

Original Prescription Strength

NDC 11523-7157-2

Non-Drowsy*

Claritin
®

RediTabs ®

loratadine 10 mg/antihistamine

Indoor & Outdoor

Allergies

*When taken as directed. See Drug Facts Panel.

24

Hour

Relief of:

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

    or Nose

No Water Needed

Melts in Your Mouth

10

ORALLY

DISINTEGRATING TABLETS

Principal Display Panel 60 Tablet Twin Pack Carton

TWIN PACK

Two 30ct Cartons

60 RediTabs
®

Original Prescription Strength

NDC 11523-4329-1

Non-Drowsy*

Claritin
®

RediTabs ®

loratadine 10 mg/antihistamine

Indoor & Outdoor

Allergies

*When taken as directed. See Drug Facts Panel.

24

Hour

Relief of:

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

    or Nose

No Water Needed

Melts in Your Mouth

60

ORALLY

DISINTEGRATING TABLETS


Structured Label Content

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 (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.

Purpose

Antihistamine

Directions
  • place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children 6 years and over 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)
  • 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

Questions Or Comments? (Questions or comments?)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Loratadine 10 mg

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

Original Prescription Strength

NDC 11523-7157-2

Non-Drowsy*

Claritin
®

RediTabs ®

loratadine 10 mg/antihistamine

Indoor & Outdoor

Allergies

*When taken as directed. See Drug Facts Panel.

24

Hour

Relief of:

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

    or Nose

No Water Needed

Melts in Your Mouth

10

ORALLY

DISINTEGRATING TABLETS

Principal Display Panel 60 Tablet Twin Pack Carton (PRINCIPAL DISPLAY PANEL - 60 Tablet Twin Pack Carton)

TWIN PACK

Two 30ct Cartons

60 RediTabs
®

Original Prescription Strength

NDC 11523-4329-1

Non-Drowsy*

Claritin
®

RediTabs ®

loratadine 10 mg/antihistamine

Indoor & Outdoor

Allergies

*When taken as directed. See Drug Facts Panel.

24

Hour

Relief of:

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

    or Nose

No Water Needed

Melts in Your Mouth

60

ORALLY

DISINTEGRATING TABLETS


Advanced Ingredient Data


Raw Label Data

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