Children's Claritin Chewable

Children's Claritin Chewable
SPL v8
SPL
SPL Set ID 20938e05-bc3e-51aa-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2018-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (5 mg)
Inactive Ingredients
Silicon Dioxide Magnesium Stearate Mannitol Cellulose, Microcrystalline Stearic Acid Aspartame

Identifiers & Packaging

Pill Appearance
Imprint: C Shape: round Color: pink Size: 10 mm Score: 1
Marketing Status
NDA Active Since 2015-09-25

Description

Loratadine 5 mg

Purpose

Antihistamine


Medication Information

Indications and Usage

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
Purpose

Antihistamine

Description

Loratadine 5 mg

Section 51727-6

aspartame, carmine, citric acid, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Section 51945-4

ages

2 years®

and older

Children's

Claritin®

Chewables

loratadine 5 mg/antihistamine

Indoor & Outdoor

Allergies

*When taken as directed.

See Drug Facts Panel

Non-Drowsy*

24 Hour Relief of:

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

Bubblegum

Flavored

10

Chewable Tablets

Section 53413-1

1-800-CLARITIN

Section 53414-9

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

Directions

adults and children 6 years and over

chew 2 tablets daily; not more than 2 tablets in 24 hours

children 2 to under 6 years of age

chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Other Information
  • phenylketonurics: contains phenylalanine 1.9 mg per tablet
  • safety sealed: do not use if the individual blister unit imprinted with Children’s Claritin® is open or torn
  • store between 20° to 25°C (68° to 77°F)
Active Ingredients

Loratadine 5 mg

When Using This Product

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask A Doctor If

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

As A Doctor Before Use If You Have

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.


Structured Label Content

Indications and Usage (34067-9)

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 51727-6 (51727-6)

aspartame, carmine, citric acid, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Section 51945-4 (51945-4)

ages

2 years®

and older

Children's

Claritin®

Chewables

loratadine 5 mg/antihistamine

Indoor & Outdoor

Allergies

*When taken as directed.

See Drug Facts Panel

Non-Drowsy*

24 Hour Relief of:

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

Bubblegum

Flavored

10

Chewable Tablets

Section 53413-1 (53413-1)

1-800-CLARITIN

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

chew 2 tablets daily; not more than 2 tablets in 24 hours

children 2 to under 6 years of age

chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Other Information (Other information)
  • phenylketonurics: contains phenylalanine 1.9 mg per tablet
  • safety sealed: do not use if the individual blister unit imprinted with Children’s Claritin® is open or torn
  • store between 20° to 25°C (68° to 77°F)
Active Ingredients

Loratadine 5 mg

When Using This Product (When using this product)

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

As A Doctor Before Use If You Have (AS a doctor before use if you have)

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.


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