TOPCARE ALLERGY RELIEF 24 HOUR- loratadine tablet

TopCare Allergy Relief by

Drug Labeling and Warnings

TopCare Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• 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)

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

Other information

• 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

OUR PHARMACISTS RECOMMEND

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

INGREDIENTS AND APPEARANCE

TOPCARE ALLERGY RELIEF  24 HOUR
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-612
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	L612
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-612-65	1 in 1 CARTON	01/25/2005
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 36800-612-72	1 in 1 CARTON	03/24/2005	08/17/2011
2		60 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 36800-612-76	1 in 1 CARTON	12/18/2009
3		120 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 36800-612-87	1 in 1 CARTON	12/18/2009
4		300 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 36800-612-46	10 in 1 CARTON	01/28/2005
5		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 36800-612-58	1 in 1 CARTON	02/19/2014
6		40 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 36800-612-03	1 in 1 CARTON	03/05/2014
7		70 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076301	01/25/2005

Labeler - Topco Associates LLC (006935977)