Loratadine Tablets Usp, 10mg

Loratadine Tablets Usp, 10mg
SPL v5
SPL
SPL Set ID f2a2a754-0170-e37c-e053-2a95a90a4dca
Route
ORAL
Published
Effective Date 2023-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: G;10 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2023-06-30

Description

Loratadine 10mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Loratadine 10mg

Pdp

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

Other Information

■ safety sealed: do not use if the individual blister unit is 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 8:00 AM EST to 5:00 PM PST

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 10mg

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

Pdp (PDP)

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

Other Information

■ safety sealed: do not use if the individual blister unit is 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? (Questions or comments?)

contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

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 10mg

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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