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NDC 51672-2108-01 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: 51672-2108-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	51672-2108
Product ID	51672-2108_31f7a7ea-9574-4641-a4ab-55f2c1f1d3e4
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	Childrens Loratadine
Proprietary Name Suffix	Sugar Free
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	ANDA201865
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51672-2108-01 (51672210801)

Pricing Information	N/A
NDC Package Code	51672-2108-1
Billing NDC	51672210801
Package	1 BOTTLE in 1 CARTON (51672-2108-1) / 240 mL in 1 BOTTLE
Marketing Start Date	2016-12-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 96a76906-58ad-40cd-be27-4ea254e298c5 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

each teaspoonful contains: sodium 5 mg
do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
store between 20° and 25°C (68° and 77°F)
see bottom panel for lot number and expiration date

Inactive ingredients

bubble gum flavor, butylated hydroxyanisole, glycerin, maltitol solution, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sucralose powder

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

Compare to the

active ingredient

in Children's Claritin®*

NDC 51672-2108-8

Children's

Loratadine

Oral Solution

USP, 5 mg/5 mL

(Antihistamine) ALLERGY

Non-Drowsy†

Indoor & Outdoor Allergies

SUGAR FREE

24

Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Ages 2 years and older

Dosing Cup

Enclosed

Bubble Gum

Flavor

†When taken as directed.

See Drug Facts Panel.

4 FL OZ

(120 mL)

Principal Display Panel - 120 mL Bottle Carton

INGREDIENTS AND APPEARANCE

CHILDRENS LORATADINE SUGAR FREE

loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51672-2108
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
butylated hydroxyanisole (UNII: REK4960K2U)
glycerin (UNII: PDC6A3C0OX)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
sorbitol (UNII: 506T60A25R)
phosphoric acid (UNII: E4GA8884NN)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51672-2108-8	1 in 1 CARTON	12/08/2016
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:51672-2108-1	1 in 1 CARTON	12/08/2016
2		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	ANDA201865	12/08/2016

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

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceutical Industries Ltd.		600072078	MANUFACTURE(51672-2108)

Revised: 4/2021

Document Id: 31f7a7ea-9574-4641-a4ab-55f2c1f1d3e4

Set id: 96a76906-58ad-40cd-be27-4ea254e298c5

Version: 5

Effective Time: 20210416

Search by Drug Name or NDC

NDC 51672-2108-01 Childrens Loratadine 5 mg/5mL Details

Childrens Loratadine 5 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 51672-2108-01 (51672210801)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 96a76906-58ad-40cd-be27-4ea254e298c5 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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