Wal-itin®

Wal-itin®
SPL v4
SPL
SPL Set ID 71adc5b3-3a91-4a1f-acb3-78922a7d9d5a
Route
ORAL
Published
Effective Date 2022-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (5 mg)
Inactive Ingredients
Aspartame Anhydrous Citric Acid Silicon Dioxide Magnesium Stearate Mannitol Microcrystalline Cellulose Stearic Acid Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: 106 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2020-08-01

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
  • chew or crush tablets completely before swallowing.
adults and children 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

Other Information
  • phenylketonurics: contains phenylalanine 1.25 mg per tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25°C (68° to 77°F).
Inactive Ingredients

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Active Ingredient (in Each Tablet)

Loratadine USP, 5 mg

Principal Display Panel 5 Mg Tablet Blister Pack Carton

NDC 0363-9994-30

Walgreens

Compare to the active ingredient

in Children's Claritin ®Chewables ††

• WALGREENS •

PHARMACIST RECOMMENDED

Children's

Allergy Relief

LORATADINE CHEWABLE TABLETS USP, 5 mg / ANTIHISTAMINE

Dye Free

Non-Drowsy*

24-Hour Relief

  • 24-hour relief of sneezing, runny nose, itchy throat or nose, & itchy, watery eyes
  • Indoor & outdoor allergies

AGES

2

YEARS &

OLDER

30 CHEWABLE TABLETS

Chewable tablets are to be chewed before swallowing.

ACTUAL SIZE

Grape

flavor

*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
  • chew or crush tablets completely before swallowing.
adults and children 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

Other Information (Other information)
  • phenylketonurics: contains phenylalanine 1.25 mg per tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25°C (68° to 77°F).
Inactive Ingredients (Inactive ingredients)

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

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

Loratadine USP, 5 mg

Principal Display Panel 5 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton)

NDC 0363-9994-30

Walgreens

Compare to the active ingredient

in Children's Claritin ®Chewables ††

• WALGREENS •

PHARMACIST RECOMMENDED

Children's

Allergy Relief

LORATADINE CHEWABLE TABLETS USP, 5 mg / ANTIHISTAMINE

Dye Free

Non-Drowsy*

24-Hour Relief

  • 24-hour relief of sneezing, runny nose, itchy throat or nose, & itchy, watery eyes
  • Indoor & outdoor allergies

AGES

2

YEARS &

OLDER

30 CHEWABLE TABLETS

Chewable tablets are to be chewed before swallowing.

ACTUAL SIZE

Grape

flavor

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.


Advanced Ingredient Data


Raw Label Data

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