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NDC 45802-0974-26 cetirizine hydrochloride 5 mg/5mL Details

cetirizine hydrochloride 5 mg/5mL

cetirizine hydrochloride is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. 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: 45802-0974-26
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	45802-0974
Product ID	45802-974_4ab6acdb-a469-4da0-9127-c75b5be16131
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	cetirizine hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	cetirizine hydrochloride
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	Padagis Israel Pharmaceuticals Ltd
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090254
Listing Certified Through	2024-12-31

Package

Package Images

NDC 45802-0974-26 (45802097426)

Pricing Information
NDC Package Code	45802-974-26
Billing NDC	45802097426
Package	1 BOTTLE in 1 CARTON (45802-974-26) / 118 mL in 1 BOTTLE
Marketing Start Date	2008-04-15
NDC Exclude Flag	N
Price Per Unit	0.03657
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 c2cf555d-986c-4e89-ac4f-938e92c418e2 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

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural banana flavor, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Children's Zyrtec® active ingredient

Children’s Cetirizine Hydrochloride Oral Solution 1 mg/mL

Antihistamine

Allergy

24 Hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

2 yrs & older

Dye-Free

Grape Syrup

4 FL OZ (118 mL)

Indoor & Outdoor Allergies

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE

cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45802-974
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
ACETIC ACID (UNII: Q40Q9N063P)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM ACETATE (UNII: 4550K0SC9B)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	YELLOW (Pale Yellow)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:45802-974-26	1 in 1 CARTON	04/15/2008
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	ANDA090254	04/15/2008

Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 11/2021

Document Id: 4ab6acdb-a469-4da0-9127-c75b5be16131

Set id: c2cf555d-986c-4e89-ac4f-938e92c418e2

Version: 4

Effective Time: 20211111