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NDC 51672-2148-01 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: 51672-2148-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	51672-2148
Product ID	51672-2148_137524f7-318b-4772-9ce7-97593c7ad2a7
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 CETIRIZINE HYDROCHLORIDE
Proprietary Name Suffix	SUGAR FREE BUBBLE GUM
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	ANDA201546
Listing Certified Through	2023-12-31

Package

Package Images

NDC 51672-2148-01 (51672214801)

Pricing Information	N/A
NDC Package Code	51672-2148-1
Billing NDC	51672214801
Package	1 BOTTLE in 1 CARTON (51672-2148-1) / 240 mL in 1 BOTTLE
Marketing Start Date	2022-06-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 69a63e8c-e225-4556-873e-9e5eb18c82f0 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
sneezing
itchy, watery eyes
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 over	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

each 5 mL contains: sodium 4 mg
do not use if carton is opened or if imprinted safety seal is broken or missing
see bottom panel for lot number and expiration date
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

bubble gum artificial flavor, glacial acetic acid, glycerin, propylene glycol, purified water, sodium acetate anhydrous, sodium benzoate, 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 51672-2148-8

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

Bubble Gum

Flavor

Dosing Cup Included

4 FL OZ

(120 mL)

Principal Display Panel - 120 mL Bottle Carton

INGREDIENTS AND APPEARANCE

CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE BUBBLE GUM

cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51672-2148
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)
propylene glycol (UNII: 6DC9Q167V3)
sodium acetate anhydrous (UNII: NVG71ZZ7P0)
sodium benzoate (UNII: OJ245FE5EU)
sucralose (UNII: 96K6UQ3ZD4)
water (UNII: 059QF0KO0R)

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:51672-2148-8	1 in 1 CARTON	06/29/2022
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:51672-2148-1	1 in 1 CARTON	06/29/2022
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	ANDA201546	06/29/2022

Labeler - TARO PHARMACEUTICALS U.S.A., INC. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceutical Industries Ltd.		600072078	MANUFACTURE(51672-2148)

Revised: 7/2022

Document Id: 137524f7-318b-4772-9ce7-97593c7ad2a7

Set id: 69a63e8c-e225-4556-873e-9e5eb18c82f0

Version: 2

Effective Time: 20220726

Search by Drug Name or NDC

NDC 51672-2148-01 CHILDRENS CETIRIZINE HYDROCHLORIDE 1 mg/mL Details

CHILDRENS CETIRIZINE HYDROCHLORIDE 1 mg/mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 51672-2148-01 (51672214801)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 69a63e8c-e225-4556-873e-9e5eb18c82f0 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each 5 mL)

Purpose

Uses

Warnings

When using this product

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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