Claritin

Claritin
SPL v1
SPL
SPL Set ID 8d59f35f-9b84-def8-e053-2995a90aaba7
Route
ORAL
Published
Effective Date 2019-07-10
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 Active Since 2019-07-03

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

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

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

Package Label

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

When Using This Product

do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask A Doctor

if an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

Loratadine 10 mg

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

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

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

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients.

Package Label

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

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 (Stop use and ask a doctor)

if an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

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

Loratadine 10 mg

Ask 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.


Advanced Ingredient Data


Raw Label Data

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