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NDC 51672-2102-08 Childrens Cetirizine Hydrochloride 1 mg/mL Details

Childrens Cetirizine Hydrochloride 1 mg/mL

Childrens Cetirizine Hydrochloride 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 CETIRIZINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Cetirizine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dust mites, animal dander, cockroaches, and molds). These symptoms include sneezing; runny nose; itchy, red, watery eyes; and itchy nose or throat. Cetirizine is also used to treat itching and redness caused by hives. However, cetirizine does not prevent hives or other allergic skin reactions. Cetirizine 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. Cetirizine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of cetirizine alone. If you are taking the cetirizine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Related Packages: 51672-2102-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	51672-2102
Product ID	51672-2102_590a6b63-2797-4ea3-a0c1-f69f68c4fae3
Associated GPIs	41550020102010
GCN Sequence Number	021687
GCN Sequence Number Description	cetirizine HCl SOLUTION 1 MG/ML ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	49290
HICL Sequence Number	006544
HICL Sequence Number Description	CETIRIZINE HCL
Brand/Generic	Generic
Proprietary Name	Childrens Cetirizine Hydrochloride
Proprietary Name Suffix	Sugar Free Grape
Non-Proprietary Name	Cetirizine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	1
Active Ingredient Units	mg/mL
Substance Name	CETIRIZINE HYDROCHLORIDE
Labeler Name	Taro Pharmaceuticals U.S.A., Inc.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090182
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51672-2102-08 (51672210208)

Pricing Information
NDC Package Code	51672-2102-8
Billing NDC	51672210208
Package	1 BOTTLE in 1 CARTON (51672-2102-8) / 120 mL in 1 BOTTLE
Marketing Start Date	2011-09-08
NDC Exclude Flag	N
Price Per Unit	0.03178
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	CETIRIZINE HCL 1 MG/ML SOLN
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 54d72d7a-1f5b-4b36-bf76-ab7aef6243ab Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

Cetirizine HCl 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 or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

if breast-feeding: not recommended
if pregnant: 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
find right dose on chart below
mL = milliliter

adults and children 6 years and over	5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours..
adults 65 years and older	5 mL once daily; do not take more than 5 mL in 24 hours
children 2 to under 6 years of age	2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL 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, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucralose

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 Zyrtec®*

NDC 51672-2102-8

Children's

Cetirizine

Hydrochloride

Oral Solution

1 mg/mL

ALLERGY

Antihistamine

Indoor & Outdoor Allergies

SUGAR FREE

24

Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

2 Yrs. & older

Grape Flavor

Dosing Cup Included

4 FL OZ

(120 mL)

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

INGREDIENTS AND APPEARANCE

CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE

cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51672-2102
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24)	Cetirizine Hydrochloride	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
acetic acid (UNII: Q40Q9N063P)
glycerin (UNII: PDC6A3C0OX)
methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium acetate anhydrous (UNII: NVG71ZZ7P0)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE, BANANA	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51672-2102-4	1 in 1 CARTON	09/08/2011
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:51672-2102-8	1 in 1 CARTON	09/08/2011
2		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:51672-2102-1	1 in 1 CARTON	09/08/2011
3		240 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:51672-2102-2	2 in 1 CARTON	09/08/2011
4		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:51672-2102-7	2 in 1 CARTON	09/08/2011
5		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	ANDA090182	09/08/2011

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

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceutical Industries, Ltd.		600072078	MANUFACTURE(51672-2102)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(51672-2102)

Revised: 4/2021

Document Id: 590a6b63-2797-4ea3-a0c1-f69f68c4fae3

Set id: 54d72d7a-1f5b-4b36-bf76-ab7aef6243ab

Version: 5

Effective Time: 20210416

Search by Drug Name or NDC

NDC 51672-2102-08 Childrens Cetirizine Hydrochloride 1 mg/mL Details

Childrens Cetirizine Hydrochloride 1 mg/mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 51672-2102-08 (51672210208)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 54d72d7a-1f5b-4b36-bf76-ab7aef6243ab Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each 5 mL)

Purpose

Uses

Warnings

When using this product

If pregnant or breast-feeding

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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