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NDC 51672-2085-05 Childrens Loratadine 5 mg/5mL Details

Childrens Loratadine 5 mg/5mL

Childrens Loratadine is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Taro Pharmaceuticals U.S.A., Inc.. 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: 51672-2085-05
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	51672-2085
Product ID	51672-2085_d8ae719e-320f-43b3-ba1c-61cfd42d164b
Associated GPIs	41550030001220
GCN Sequence Number	018697
GCN Sequence Number Description	loratadine SOLUTION 5 MG/5 ML ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	60562
HICL Sequence Number	007605
HICL Sequence Number Description	LORATADINE
Brand/Generic	Generic
Proprietary Name	Childrens Loratadine
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	Taro Pharmaceuticals U.S.A., Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076805
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51672-2085-05 (51672208505)

Pricing Information	N/A
NDC Package Code	51672-2085-5
Billing NDC	51672208505
Package	1 BOTTLE in 1 CARTON (51672-2085-5) / 180 mL in 1 BOTTLE
Marketing Start Date	2004-08-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 12c8066a-3429-481e-b63a-7ea2b439a170 Details

SPL UNCLASSIFIED SECTION

Drug Facts

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 imprinted safety seal is broken or missing
see bottom panel for expiration date
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:

Taro Pharmaceuticals U.S.A., Inc.

Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC xxxxx-xxxx-x

Compare to the

active ingredient

in Children's Claritin®*

GRAPE

FLAVOR

Original

Prescription Strength

Ages two years and older

Children's

Loratadine

Syrup

(Loratadine

Oral Solution)

5 mg/5 mL

Antihistamine

Grape Flavored Syrup

24 Hour Non-Drowsy†

Allergy Relief

Indoor &

Outdoor

Allergies

Relief of:

Sneezing; Runny Nose,

Itchy, Watery Eyes,

Itchy Throat or Nose

4 FL OZ (120 mL)

† When taken as directed. See Drug Facts Panel.

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

INGREDIENTS AND APPEARANCE

CHILDRENS LORATADINE

loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51672-2085
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
citric acid monohydrate (UNII: 2968PHW8QP)
glycerin (UNII: PDC6A3C0OX)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sodium metabisulfite (UNII: 4VON5FNS3C)
sucrose (UNII: C151H8M554)

Product Characteristics
Color	YELLOW (colorless to slightly yellow)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51672-2085-8	1 in 1 CARTON	08/20/2004
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:51672-2085-4	1 in 1 CARTON	08/20/2004
2		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:51672-2085-5	1 in 1 CARTON	08/20/2004
3		180 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:51672-2085-1	1 in 1 CARTON	08/20/2004
4		240 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	ANDA076805	08/20/2004

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceutical Industries Ltd.		600072078	MANUFACTURE(51672-2085)

Revised: 1/2020

Document Id: d8ae719e-320f-43b3-ba1c-61cfd42d164b

Set id: 12c8066a-3429-481e-b63a-7ea2b439a170

Version: 3

Effective Time: 20200124

Search by Drug Name or NDC

NDC 51672-2085-05 Childrens Loratadine 5 mg/5mL Details

Childrens Loratadine 5 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 51672-2085-05 (51672208505)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 12c8066a-3429-481e-b63a-7ea2b439a170 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each 5 mL teaspoonful)

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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