Claritin®

Claritin®
SPL v2
SPL
SPL Set ID 677bf76d-e75d-4212-b1f2-eaaf25b27cb7
Route
ORAL
Published
Effective Date 2022-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 458;Claritin10 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
NDA Active Since 2011-12-15

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
  • sneezing
  • itchy, watery eyes
  • 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 (1-800-222-1222).

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
  • store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature)
Inactive Ingredients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments?

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

Active Ingredient (in Each Tablet)

Loratadine, USP 10 mg

Principal Display Panel 10 Mg Pouch Blister Pack

Non-Drowsy*

Claritin®

loratadine tablets 10 mg/antihistamine

Original Prescription Strength

24

Hour

Relief of:

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

Indoor & Outdoor

Allergies

*When taken as directed.

See Drug Facts Panel.

1 Tablet


Structured Label Content

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • 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 (1-800-222-1222).

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 (Other information)
  • store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature)
Inactive Ingredients (Inactive ingredients)

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

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, USP 10 mg

Principal Display Panel 10 Mg Pouch Blister Pack (PRINCIPAL DISPLAY PANEL - 10 mg Pouch Blister Pack)

Non-Drowsy*

Claritin®

loratadine tablets 10 mg/antihistamine

Original Prescription Strength

24

Hour

Relief of:

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

Indoor & Outdoor

Allergies

*When taken as directed.

See Drug Facts Panel.

1 Tablet


Advanced Ingredient Data


Raw Label Data

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