Loratadine

Loratadine
SPL v5
SPL
SPL Set ID 3881afaf-8d0d-4154-85a8-79a3c7806b49
Route
ORAL
Published
Effective Date 2023-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (5 mg)
Inactive Ingredients
Butylated Hydroxyanisole Glycerin Maltitol Sorbitol Phosphoric Acid Polyethylene Glycol, Unspecified Propylene Glycol Water Sucralose Sodium Benzoate Sodium Phosphate, Monobasic, Dihydrate

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
ANDA Active Since 2023-04-19

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9

Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

Do not useif you have ever had an allergic reaction to this product or any of its ingredients.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Directions
  • use only with enclosed dosing cup
adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
Questions?

Call 1-866-923-4914

Other Information
  • each teaspoonful contains:sodium 5 mg
  • do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
  • store between 20° and 25°C (68° and 77°F)
  • see bottom panel for lot number and expiration date
Inactive Ingredients

bubble gum flavor, butylated hydroxyanisole, glycerin, maltitol solution, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sucralose powder

Active Ingredient (in Each 5 Ml Teaspoonful)

Loratadine 5 mg

Principal Display Panel 120 Ml Bottle Carton

NDC 0363-0771-08

Walgreens

Compare to the active ingredient

in Children's Claritin ®

• WALGREENS •

PHARMACIST RECOMMENDED

Children's

Allergy

Relief

LORATADINE

ORAL SOLUTION USP 5mg/5mL

(ANTIHISTAMINE) ALLERGY

Dye Free

Sugar Free

24-Hour Relief

Non-Drowsy*

  • 24-hour relief of

    runny nose; sneezing;

    itchy throat or nose

    & itchy, watery eyes
  • Indoor & outdoor

    allergies

AGES

2

YEARS &

OLDER

4 FL OZ (120 mL)

Bubble Gum

flavor


Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9 (50566-9)

Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3 (50569-3)

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

Do not useif you have ever had an allergic reaction to this product or any of its ingredients.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Antihistamine

Directions
  • use only with enclosed dosing cup
adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
Questions?

Call 1-866-923-4914

Other Information (Other information)
  • each teaspoonful contains:sodium 5 mg
  • do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
  • store between 20° and 25°C (68° and 77°F)
  • see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

bubble gum flavor, butylated hydroxyanisole, glycerin, maltitol solution, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sucralose powder

Active Ingredient (in Each 5 Ml Teaspoonful) (Active ingredient (in each 5 mL teaspoonful))

Loratadine 5 mg

Principal Display Panel 120 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton)

NDC 0363-0771-08

Walgreens

Compare to the active ingredient

in Children's Claritin ®

• WALGREENS •

PHARMACIST RECOMMENDED

Children's

Allergy

Relief

LORATADINE

ORAL SOLUTION USP 5mg/5mL

(ANTIHISTAMINE) ALLERGY

Dye Free

Sugar Free

24-Hour Relief

Non-Drowsy*

  • 24-hour relief of

    runny nose; sneezing;

    itchy throat or nose

    & itchy, watery eyes
  • Indoor & outdoor

    allergies

AGES

2

YEARS &

OLDER

4 FL OZ (120 mL)

Bubble Gum

flavor


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)