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NDC 36800-0608-26 topcare childrens allergy 5 mg/5mL Details

topcare childrens allergy 5 mg/5mL

topcare childrens allergy is a ORAL SOLUTION 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: 36800-0608-26
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	36800-0608
Product ID	36800-608_3e49bf56-baef-4c33-a38b-a25794c15622
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 childrens allergy
Proprietary Name Suffix	n/a
Non-Proprietary Name	loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/5mL
Substance Name	LORATADINE
Labeler Name	Topco Associates LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075728
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0608-26 (36800060826)

Pricing Information	N/A
NDC Package Code	36800-608-26
Billing NDC	36800060826
Package	1 BOTTLE in 1 CARTON (36800-608-26) / 120 mL in 1 BOTTLE
Marketing Start Date	2020-07-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6e175fae-05dd-45c2-b9ab-7d49369a3c05 Details

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 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

•: use only with enclosed dosing cup

adults and children 6 years and over	2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age	1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

•: do not use if carton is opened, or if printed neckband is broken or missing
•: store between 20° to 25°C (68° to 77°F)

Inactive ingredients

edetate disodium, glycerin, maltitol, monobasic sodium phosphate, natural and artificial grape flavor, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

TopCare® health

COMPARE TO CHILDREN’S CLARITIN® ACTIVE INGREDIENT

children’s Allergy

LORATADINE ORAL SUSPENSION USP, 5 mg/5mL (ANTIHISTAMINE) / ALLERGY

INDOOR & OUTDOOR ALLERGIES

24 HOUR

24 HOUR RELIEF OF:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

Sugar Free & Dye Free

ALCOHOL FREE

NON-DROWSY†

Dosing Cup Enclosed

Ages 2 Years and older

GRAPE FLAVOR

4 FL OZ (120 mL)

†When taken as directed. See Drug Facts Panel.

INGREDIENTS AND APPEARANCE

TOPCARE CHILDRENS ALLERGY

loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-608
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
PHOSPHORIC ACID (UNII: E4GA8884NN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-608-26	1 in 1 CARTON	07/08/2020
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075728	07/08/2020

Labeler - Topco Associates LLC (006935977)

Revised: 2/2022

Document Id: 3e49bf56-baef-4c33-a38b-a25794c15622

Set id: 6e175fae-05dd-45c2-b9ab-7d49369a3c05

Version: 3

Effective Time: 20220228