Children's Wal-itin®

Children's Wal-itin®
SPL v3
SPL
SPL Set ID 14614dc4-2ed1-4601-9873-e38d74344ce8
Route
ORAL
Published
Effective Date 2014-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (5 mg)
Inactive Ingredients
Glycerin Sorbitol Phosphoric Acid Polyethylene Glycols Propylene Glycol Water Sodium Benzoate Sodium Metabisulfite Sodium Phosphate, Monobasic, Dihydrate

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
ANDA Active Since 2010-02-27

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
  • itchy, watery eyes
  • sneezing
  • 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 if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

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

Section 50569-3

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

Section 50570-1

Do not use if 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
  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 20° and 25°C (68° and 77°F)
Inactive Ingredients

glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium phosphate monobasic dihydrate, sucralose powder.

Active Ingredient (in Each 5 Ml Teaspoonful)

Loratadine 5 mg

Principal Display Panel 120 Ml Bottle Carton

Well at

Walgreens

NDC 0363-2092-08

WALGREENS PHARMACIST RECOMMENDED

children's

Wal-itin®

Loratadine Oral Solution

5 mg/5 mL / Antihistamine

Allergy

  • Alcohol free
  • Sugar free
  • Relief of runny nose, sneezing,

    itchy throat or nose & itchy,

    watery eyes
  • Non-drowsy*
  • Ages 2 years & older

DYE &

SUGAR

FREE

INDOOR &

OUTDOOR

ALLERGIES

24

HOUR

RELIEF

4 FL OZ (120 mL)

GRAPE

FLAVOR

Compare to Children's Claritin®

active ingredient‡‡

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.


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

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use if 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)
  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 20° and 25°C (68° and 77°F)
Inactive Ingredients (Inactive ingredients)

glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, 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)

Well at

Walgreens

NDC 0363-2092-08

WALGREENS PHARMACIST RECOMMENDED

children's

Wal-itin®

Loratadine Oral Solution

5 mg/5 mL / Antihistamine

Allergy

  • Alcohol free
  • Sugar free
  • Relief of runny nose, sneezing,

    itchy throat or nose & itchy,

    watery eyes
  • Non-drowsy*
  • Ages 2 years & older

DYE &

SUGAR

FREE

INDOOR &

OUTDOOR

ALLERGIES

24

HOUR

RELIEF

4 FL OZ (120 mL)

GRAPE

FLAVOR

Compare to Children's Claritin®

active ingredient‡‡

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.


Advanced Ingredient Data


Raw Label Data

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