Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 636d7948-1974-49e7-9571-7a7c3463c415
Route
ORAL
Published
Effective Date 2018-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Starch, Corn Lactose Monohydrate Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: RX526 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2013-12-05

Description

Loratadine, USP 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Loratadine, USP 10 mg

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

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Directions
adults and children 6 years and over 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
Do Not Use

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

Questions?

Call 1-800-406-7984

Other Information
  • store between 20° to 25° C (68° to 77° F)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

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.

If Pregnant Or Breast Feeding,

Ask a health professional before use.

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).

Active Ingredient (in Each Tablet)

Loratadine, USP 10 mg

Ask A Doctor Before Use If You Have

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

Principal Display Panel 10 Mg Tablet Blister Pack Carton

NON-DROWSY*

Wal-itin®

24 Hour Allergy

Loratadine Tablets, USP 10 mg

Antihistamine

  • Relief of runny nose,

    sneezing, itchy throat or nose &

    itchy, watery eyes

5 TABLETS

Actual Size

Well at

Walgreens

WALGREENS PHARMACIST RECOMMENDED

NDC 0363-0522-56

INDOOR &

OUTDOOR

ALLERGIES

24

HOUR

Compare to Claritin®

active ingredient‡‡

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.


Structured Label Content

Uses (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)

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Purpose (PURPOSE)

Antihistamine

Directions (DIRECTIONS)
adults and children 6 years and over 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
Do Not Use (Do not use)

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

Questions? (QUESTIONS?)

Call 1-800-406-7984

Other Information (OTHER INFORMATION)
  • store between 20° to 25° C (68° to 77° F)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Inactive Ingredients (INACTIVE INGREDIENTS)

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

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 If (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding, (If 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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (IN EACH TABLET))

Loratadine, USP 10 mg

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.

Principal Display Panel 10 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton)

NON-DROWSY*

Wal-itin®

24 Hour Allergy

Loratadine Tablets, USP 10 mg

Antihistamine

  • Relief of runny nose,

    sneezing, itchy throat or nose &

    itchy, watery eyes

5 TABLETS

Actual Size

Well at

Walgreens

WALGREENS PHARMACIST RECOMMENDED

NDC 0363-0522-56

INDOOR &

OUTDOOR

ALLERGIES

24

HOUR

Compare to Claritin®

active ingredient‡‡

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.


Advanced Ingredient Data


Raw Label Data

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