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Topcare Allergy Relief 24 Hour: Package Insert / Prescribing Info

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

Medically reviewed by Drugs.com. Last updated on Feb 28, 2024.

Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Indications and Usage for Topcare Allergy Relief 24 Hour

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

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 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)

Topcare Allergy Relief 24 Hour Dosage and Administration

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

Storage and Handling

•
do not use if blister unit is broken or torn
•
store between 20° to 25°C (68° to 77°F)
•
protect from excessive moisture

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-888-423-0139

Principal Display Panel

COMPARE TO CLARITIN® TABLETS ACTIVE INGREDIENT

NON-DROWSY*

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief

LORATADINE TABLETS, 10 mg ● ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

● Sneezing

● Runny Nose

● Itchy, Watery Eyes

● Itchy Throat or Nose

10 TABLETS

*When taken as directed. See Drug Facts Panel.

actual size

61288-allergy-relief
TOPCARE ALLERGY RELIEF 24 HOUR
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-612
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize8mm
FlavorImprint CodeL612
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-612-651 in 1 CARTON01/25/2005
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:36800-612-721 in 1 CARTON03/24/200508/17/2011
260 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:36800-612-761 in 1 CARTON12/18/200911/20/2021
3120 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:36800-612-871 in 1 CARTON12/18/2009
4300 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:36800-612-4610 in 1 CARTON01/28/2005
51 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:36800-612-581 in 1 CARTON02/19/2014
640 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:36800-612-031 in 1 CARTON03/05/2014
770 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07630101/25/2005
Labeler - Topco Associates LLC (006935977)

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