Claritin

Claritin
SPL v3
SPL
SPL Set ID 60a5dc14-3f74-8414-e053-2991aa0ad34a
Route
ORAL
Published
Effective Date 2017-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Starch, Corn Anhydrous Lactose Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: 458;Claritin10 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
NDA Completed Since 2017-12-04 Until 2025-07-01

Description

Loratadine 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Loratadine 10 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
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
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 ® is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture
Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate

Questions Or Comments?

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

Active Ingredient (in Each Tablet)

Loratadine 10 mg

Principle Display Panel 12 Pouch Dispensit


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 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
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 ® is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture
Inactive Ingredients (Inactive ingredients)

corn starch, lactose monohydrate, magnesium stearate

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

Principle Display Panel 12 Pouch Dispensit (Principle Display Panel - 12 Pouch Dispensit)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)