Claritin ®

Claritin ®
SPL v8
SPL
SPL Set ID f85b0527-107c-4a4a-aad7-61d2f52bad63
Route
ORAL
Published
Effective Date 2017-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 458;Claritin10 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
NDA Active Since 2020-11-03

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
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

Principal Display Panel Cvp

Original Prescription Strength

Non-Drowsy* Claritin ® loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

Sneezing Runny Nose Itchy,

Watery Eyes

Itchy Throat

or Nose

Indoor & Outdoor Allergies

[Bayer cross]*When taken as directed. See Drug Facts Panel.

1 Tablet

[tablet image]

CVP

HEALTH

Active Ingredient (in Each Tablet)

Loratadine 10 mg

Principal Display Panel/package Bsx

Original Prescription Strength

Non-Drowsy* Claritin ® loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy,

Watery Eyes

  • Itchy Throat

or Nose

Indoor & Outdoor Allergies

[Bayer cross]* When taken as directed.

See Drug Facts Panel.

1 Tablet

[tablet image]

TRAVEL

BASIX

Principal Display Panel 1 Tablet Pouch Carton Lil' Drug Store

Original Prescription Strength

Non-Drowsy* Claritin ® loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy,

Watery Eyes

  • Itchy Throat

or Nose

*When taken as directed. See Drug Facts Panel.

Indoor & Outdoor Allergies

1 Tablet


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
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 ® 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

Principal Display Panel Cvp (Principal Display Panel - CVP)

Original Prescription Strength

Non-Drowsy* Claritin ® loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

Sneezing Runny Nose Itchy,

Watery Eyes

Itchy Throat

or Nose

Indoor & Outdoor Allergies

[Bayer cross]*When taken as directed. See Drug Facts Panel.

1 Tablet

[tablet image]

CVP

HEALTH

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

Loratadine 10 mg

Principal Display Panel/package Bsx (Principal Display Panel/Package - BSX)

Original Prescription Strength

Non-Drowsy* Claritin ® loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy,

Watery Eyes

  • Itchy Throat

or Nose

Indoor & Outdoor Allergies

[Bayer cross]* When taken as directed.

See Drug Facts Panel.

1 Tablet

[tablet image]

TRAVEL

BASIX

Principal Display Panel 1 Tablet Pouch Carton Lil' Drug Store (PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch Carton - Lil' Drug Store)

Original Prescription Strength

Non-Drowsy* Claritin ® loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy,

Watery Eyes

  • Itchy Throat

or Nose

*When taken as directed. See Drug Facts Panel.

Indoor & Outdoor Allergies

1 Tablet


Advanced Ingredient Data


Raw Label Data

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