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

Purpose

Antihistamine

Description

Loratadine 10 mg


Medication Information

Active Ingredient

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

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

corn starch, lactose monohydrate, magnesium stearate

Description

Loratadine 10 mg

Do Not Use

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

Package Label

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.

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

Active Ingredient (Active ingredient (in each tablet))

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

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

Do Not Use (Do not use)

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

Package Label

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.

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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