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NDC 36800-0853-65 Topcare Allergy Relief 10 mg/1 Details

Topcare Allergy Relief 10 mg/1

Topcare Allergy Relief is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is LORATADINE.

MedlinePlus Drug Summary

Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include sneezing, runny nose, and itchy eyes, nose, or throat. Loratadine is also used to treat itching and redness caused by hives. However, loratadine does not prevent hives or other allergic skin reactions. Loratadine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Loratadine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of loratadine alone. If you are taking the loratadine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Related Packages: 36800-0853-65
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	36800-0853
Product ID	36800-853_4bd57bff-c68b-497f-801d-e60d9c7b8390
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Topcare Allergy Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, ORALLY DISINTEGRATING
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	Topco Associates LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076011
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0853-65 (36800085365)

Pricing Information	N/A
NDC Package Code	36800-853-65
Billing NDC	36800085365
Package	30 BLISTER PACK in 1 CARTON (36800-853-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date	2020-06-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 32f4e1d1-c830-4752-8251-bcc233bf03f6 Details

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

•: place 1 tablet on tongue; tablet disintegrates, with or without water

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 printed blister unit is broken or torn
•: store between 20° to 25°C (68° to 77°F)
•: use tablet immediately after opening individual blister

Inactive ingredients

croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial mint flavor, sucralose

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

COMPARE TO CLARITIN® REDITABS® ACTIVE INGREDIENT†

NON-DROWSY*

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief

LORATADINE ORALLY DISINTEGRATING TABLETS, 10 mg – ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

● Sneezing

● Runny Nose

● Itchy, Watery Eyes

● Itchy Throat or Nose

No Water Needed

Melts in Your Mouth

30 TABLETS

*When taken as directed. See Drug Facts Panel.

actual size

INGREDIENTS AND APPEARANCE

TOPCARE ALLERGY RELIEF

loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-853
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	L;L
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-853-65	30 in 1 CARTON	06/25/2020
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076011	06/25/2020

Labeler - Topco Associates LLC (006935977)

Revised: 11/2021

Document Id: 4bd57bff-c68b-497f-801d-e60d9c7b8390

Set id: 32f4e1d1-c830-4752-8251-bcc233bf03f6

Version: 3

Effective Time: 20211129