Loratadine

Loratadine
SPL v1
SPL
SPL Set ID 8b090fa2-9535-456c-b14d-187a2873cdf7
Route
ORAL
Published
Effective Date 2025-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Starch, Corn Lactose Monohydrate Magnesium Stearate Povidone

Identifiers & Packaging

Pill Appearance
Imprint: P;10 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2025-10-01

Description

Loratadine USP 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Loratadine USP 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.

Other Information

• Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

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

Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate, povidone

Questions Or Comments?

Call + 1-908-242-6108

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.

Package Labeling: 82725 0142 1

Package Labeling: 82725 0142 2

Package Labeling: 82725 0142 3

Package Labeling: 82725 0142 4

Active Ingredient (in Each Tablet)

Loratadine USP 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.

Other Information (Other information)

• Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

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

Inactive Ingredients (Inactive ingredients)

corn starch, lactose monohydrate, magnesium stearate, povidone

Questions Or Comments? (Questions or Comments?)

Call + 1-908-242-6108

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.

Package Labeling: 82725 0142 1 (Package Labeling: 82725-0142-1)

Package Labeling: 82725 0142 2 (Package Labeling: 82725-0142-2)

Package Labeling: 82725 0142 3 (Package Labeling: 82725-0142-3)

Package Labeling: 82725 0142 4 (Package Labeling: 82725-0142-4)

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

Loratadine USP 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

All Sections (JSON)