TOPCARE ALLERGY RELIEF- loratadine capsule, liquid filled

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 capsule)

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 capsule daily; not more than 1 capsule 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 freezing

Inactive ingredients

FD&C blue no.1, gelatin, glycerin, hydrolyzed collagen, hypromellose, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

TopCare® health

COMPARE TO CLARITIN® LIQUI-GELS® ACTIVE INGREDIENT

NON-DROWSY*

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief Liquid-Gels

LORATADINE CAPSULES, 10 mg ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

30 LIQUID-FILLED CAPSULES

*When taken as directed.

See Drug Facts Panel.

actual size

INGREDIENTS AND APPEARANCE

TOPCARE ALLERGY RELIEF 
loratadine capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-755
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MANNITOL (UNII: 3OWL53L36A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (clear)	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	446
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-755-39	30 in 1 CARTON	08/02/2020
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 36800-755-52	10 in 1 CARTON	08/02/2020
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202538	08/02/2020

Labeler - Topco Associates LLC (006935977)