Wal-itin®

Wal-itin®
SPL v2
SPL
SPL Set ID bb7392d6-77b9-42d3-82d2-8b21715774c8
Route
ORAL
Published
Effective Date 2012-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (5 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Propylene Glycol Water Sodium Benzoate Sodium Metabisulfite Sucrose

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
ANDA Active Since 2004-08-20

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.

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
adults and children

6 years and over
2 teaspoonfuls daily; do not take

more than 2 teaspoonfuls in 24 hours
children 2 to under

6 years of age
1 teaspoonful daily; do not take more

than 1 teaspoonful in 24 hours
consumers with liver

or kidney disease
ask a doctor
Active Ingredient

Loratadine 5 mg

Other Information
  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 2° and 25°C (36° and 77°F)
Inactive Ingredients

artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

Stop Use and Ask A Doctor If
  • an allergic reaction to this product occurs. Seek medical help right away.
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
Principal Display Panel 120 Ml Bottle Carton

Compare to Children's

Claritin
†® active ingredient

NDC 0363-2085-08

Walgreens

Ages 2 Years

& Older

24 HOUR

ALLERGY RELIEF

Children's Non-Drowsy*

WAL-ITIN ®

Loratadine Oral Solution,

5mg/5mL Antihistamine

Allergy Relief

Alcohol-Free

Relief of:

  • Sneezing • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Dye-Free

Original Prescription Strength

GRAPE

FLAVORED SYRUP

4 FL OZ (120 mL)

* 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.

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
adults and children

6 years and over
2 teaspoonfuls daily; do not take

more than 2 teaspoonfuls in 24 hours
children 2 to under

6 years of age
1 teaspoonful daily; do not take more

than 1 teaspoonful in 24 hours
consumers with liver

or kidney disease
ask a doctor
Active Ingredient (Active ingredient)

Loratadine 5 mg

Other Information (Other information)
  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 2° and 25°C (36° and 77°F)
Inactive Ingredients (Inactive ingredients)

artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

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.
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
Principal Display Panel 120 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton)

Compare to Children's

Claritin
†® active ingredient

NDC 0363-2085-08

Walgreens

Ages 2 Years

& Older

24 HOUR

ALLERGY RELIEF

Children's Non-Drowsy*

WAL-ITIN ®

Loratadine Oral Solution,

5mg/5mL Antihistamine

Allergy Relief

Alcohol-Free

Relief of:

  • Sneezing • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Dye-Free

Original Prescription Strength

GRAPE

FLAVORED SYRUP

4 FL OZ (120 mL)

* When taken as directed. See Drug Facts Panel.


Advanced Ingredient Data


Raw Label Data

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