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NDC 00904-6765-20 childrens cetirizine hydrochloride 5 mg/5mL Details

childrens cetirizine hydrochloride 5 mg/5mL

childrens cetirizine hydrochloride is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. 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: 00904-6765-20
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	00904-6765
Product ID	0904-6765_6a59e630-2a83-4093-bc3b-1f15a12d359e
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	n/a
Non-Proprietary Name	Cetirizine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/5mL
Substance Name	CETIRIZINE HYDROCHLORIDE
Labeler Name	Major Pharmaceuticals
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA204226
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00904-6765-20 (00904676520)

Pricing Information
NDC Package Code	0904-6765-20
Billing NDC	00904676520
Package	1 BOTTLE in 1 CARTON (0904-6765-20) / 118 mL in 1 BOTTLE
Marketing Start Date	2018-08-22
NDC Exclude Flag	N
Price Per Unit	0.03657
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	CHILD CETIRIZINE HCL 1 MG/ML
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 db297aa4-4384-48f2-b2bd-c842efc8a844 Details

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

•: store between 20° to 25°C (68° to 77°F)
•: do not use if carton is opened, or if printed neckband is broken or missing
•: see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions or comments?

1-800-616-2471

Package/Label Principal Display Panel

COMPARE TO the active ingredient of CHILDREN’S ZYRTEC®

Children’s Cetirizine Hydrochloride Oral Solution 1 mg/mL

Antihistamine

ALLERGY

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF:

Sneezing / Runny Nose

Itchy, Watery Eyes / Itchy Throat or Nose

4 FL OZ

24 Hour

(118 mL)

2yrs & older

Dosing Cup Included

Dye-Free

Sugar-Free

Grape Flavored Syrup

INGREDIENTS AND APPEARANCE

CHILDRENS CETIRIZINE HYDROCHLORIDE

cetirizine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6765
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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:0904-6765-20	1 in 1 CARTON	08/22/2018
1		118 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	ANDA204226	08/22/2018

Labeler - Major Pharmaceuticals (191427277)

Revised: 8/2020

Document Id: 6a59e630-2a83-4093-bc3b-1f15a12d359e

Set id: db297aa4-4384-48f2-b2bd-c842efc8a844

Version: 2

Effective Time: 20200826