CHILDRENS DIMETAPP NON-DROWSY ALLERGY ODT - loratadine tablet, orally disintegrating 
Richmond Division of Wyeth

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Children’s Dimetapp Non-Drowsy Allergy ODT
(loratadine)

DRUG FACTS

ACTIVE INGREDIENT (IN EACH TABLET)

Loratadine 10 mg

PURPOSE

Antihistamine

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

WARNINGS

Do not use

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

Ask a doctor before use if you have

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

When using this product

do not use more than directed. Taking more than recommended 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.

DIRECTIONS

• tablet melts in mouth. Can be taken with or without water.

Age	Dose
adults and children 6 years and over	1 tablet daily; do not use more than 1 tablet daily
children under 6	ask a doctor
consumers who have liver or kidney disease	ask a doctor

OTHER INFORMATION

• Phenylketonurics: Contains Phenylalanine 8.4 mg per tablet
• store at 20-25ºC (68-77ºF)
• keep in a dry place

INACTIVE INGREDIENTS

artificial & natural flavor, aspartame, citric acid, colloidal silicon dioxide, corn syrup solids, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, modified food starch, sodium bicarbonate

QUESTIONS OR COMMENTS?

call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Children’s Dimetapp ND Non-Drowsy* Allergy

Loratadine Orally Disintegrating Tablet, 10mg, Antihistamine

24 Hr. Relief of:

Sneezing, Runny Nose,

Itchy, Watery Eyes,

Itching of Nose & Throat

24 Hour

COOL BLAST

MELTS IN YOUR MOUTH

12 Orally Disintegrating Tablets

*When taken as directed, see DRUG FACTS Panel.

Visit our website at www.dimetapp.com

Wyeth

Distributed by: Wyeth Consumer Healthcare

Madison, NJ 07940

EACH TABLET IS BLISTER SEALED. DO NOT USE IF SEAL IS BROKEN.

CHILDRENS DIMETAPP NON-DROWSY ALLERGY ODT  loratadine   tablet, orally disintegrating

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0031-2288 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength loratadine (loratadine) loratadine 10 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE (white to off white) Score no score Shape ROUND (flat faced round beveled tablet) Size 10mm Flavor MINT (Flat minty flavor) Imprint Code A;24 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0031-2288-10 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 6 BLISTER In 1 BLISTER PACK This package is contained within the CARTON (0031-2288-10) 2 0031-2288-06 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0031-2288-06)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA0750822	12/03/2002	09/01/2008

Labeler - Richmond Division of Wyeth (829390827)

Revised: 06/2009Richmond Division of Wyeth