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Dimetapp, Childrens Non-Drowsy Allergy ODT Prescribing Information

Package insert / product label
Generic name: loratadine
Dosage form: tablet, orally disintegrating
Drug class: Antihistamines

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

The Dimetapp Children's ND Non-Drowsy Allergy brand name has been discontinued in the U.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available.

DRUG FACTS

ACTIVE INGREDIENT (IN EACH TABLET)

Loratadine 10 mg

PURPOSE

Antihistamine

Indications and Usage for Dimetapp, Childrens Non-Drowsy Allergy ODT

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 over1 tablet daily; do not use more than 1 tablet daily
children under 6ask a doctor
consumers who have liver or kidney diseaseask 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.

Children's Dimetapp ND (Non-Drowsy) Allergy Packaging
CHILDRENS DIMETAPP NON-DROWSY ALLERGY ODT
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2288
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
loratadine (UNII: 7AJO3BO7QN) (loratadine - UNII:7AJO3BO7QN) loratadine10 mg
Product Characteristics
ColorWHITE (white to off white) Scoreno score
ShapeROUND (flat faced round beveled tablet) Size10mm
FlavorMINT (Flat minty flavor) Imprint CodeA;24
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-2288-102 in 1 CARTON
16 in 1 BLISTER PACK
2NDC:0031-2288-061 in 1 CARTON
26 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07582212/03/200209/01/2008
Labeler - Richmond Division of Wyeth (829390827)

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