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

Purpose

Antihistamine

Description

Loratadine 10mg


Medication Information

Active Ingredient

Loratadine 10mg

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 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

Description

Loratadine 10mg

Pdp

Do Not Use

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

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.

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 10mg

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 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

Pdp (PDP)

Do Not Use (Do not use)

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

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.

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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