SPL v2
SPL
SPL Set ID 32619143-a782-3497-e063-6394a90aaaec
Route
ORAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-18

Description

Loratadine 10 mg.....................................................................................................Antihistamine


Medication Information

Warnings and Precautions

Indications and Usage

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

Dosage and Administration

Description

Loratadine 10 mg.....................................................................................................Antihistamine

Section 50567-7

Adults and children 6 years and older 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

Section 55105-1

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
Do Not Use

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

Other Information

  • store between 20° to 25°C (68°-77° F)
  • protect from excessive moisture
  • do not use if blister unit is torn or open
  • retain carton for complete product information.
Innactive Ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate.

Questions and Comments?

Call 1-833-999-7795

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.

I Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Loratadine 10 mg.....................................................................................................Antihistamine

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

Package Label.principal Display Panel


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 50567-7 (50567-7)

Adults and children 6 years and older 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

Section 55105-1 (55105-1)

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
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)

  • store between 20° to 25°C (68°-77° F)
  • protect from excessive moisture
  • do not use if blister unit is torn or open
  • retain carton for complete product information.
Innactive Ingredients (Innactive ingredients)

lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate.

Questions and Comments?

Call 1-833-999-7795

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 (Stop use and ask a doctor)

if an allergic reaction to this product occurs. Seek medical help right away.

I Pregnant Or Breast Feeding (I 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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

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

Loratadine 10 mg.....................................................................................................Antihistamine

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.

Package Label.principal Display Panel (Package Label.Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)