Loratadine Tablets Usp, 10mg

Loratadine Tablets Usp, 10mg
SPL v4
SPL
SPL Set ID fd796139-ea9f-f4db-e053-6394a90acdf3
Route
ORAL
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Sodium Starch Glycolate Type A Potato Starch, Corn Magnesium Stearate Lactose Monohydrate

Identifiers & Packaging

Pill Appearance
Imprint: G;10 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2024-01-01

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

Warnings

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

Directions

adults and children 1 tablet daily; not more than 1 tablet in 24 hours

6 years and over

children under ask a doctor

6 years of age

consumers with liver ask a doctor

or kidney disease

Other Information

■ safety sealed: do not use if the individual blister unit if open or torn

■ store between 20° to 25° C (68° to 77°F)

■ protect from excessive moisture

Inactive Ingredients

Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

Questions Or Comments?

Contact 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

Principal Display Panel

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

Warnings

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

Directions

adults and children 1 tablet daily; not more than 1 tablet in 24 hours

6 years and over

children under ask a doctor

6 years of age

consumers with liver ask a doctor

or kidney disease

Other Information (Other information)

■ safety sealed: do not use if the individual blister unit if open or torn

■ store between 20° to 25° C (68° to 77°F)

■ protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

Questions Or Comments? (Questions or comments?)

Contact 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

Principal Display Panel

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.

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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