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

Purpose

Antihistamine

Description

Loratadine USP 10 mg


Medication Information

Active Ingredient

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

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

• 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

Description

Loratadine USP 10 mg

Do Not Use

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

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

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 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

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 (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

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?)

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)

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)