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NDC 69230-0316-11 CHILDRENS ALLERGY RELIEF 1 mg/mL Details

CHILDRENS ALLERGY RELIEF 1 mg/mL

CHILDRENS ALLERGY RELIEF is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Camber Consumer Care. 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: 69230-0316-11
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	69230-0316
Product ID	69230-316_941e4aa9-6388-424c-87ad-3ea2ec5aafea
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 ALLERGY RELIEF
Proprietary Name Suffix	n/a
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	Camber Consumer Care
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA210622
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69230-0316-11 (69230031611)

Pricing Information
NDC Package Code	69230-316-11
Billing NDC	69230031611
Package	1 BOTTLE in 1 CARTON (69230-316-11) / 118 mL in 1 BOTTLE
Marketing Start Date	2019-03-13
NDC Exclude Flag	N
Price Per Unit	0.03657
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	CHILD ALLERGY RELIEF 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 941e4aa9-6388-424c-87ad-3ea2ec5aafea Details

ACTIVE INGREDIENT(S)

(in each 5 mL)

Cetirizine Hydrochloride USP 5mg

PURPOSE

Antihistamine

USE(S)

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 bottle wrap imprinted “SAFETY SEAL®” is broken or missing
see top panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, flavors, non crystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate and sucralose.

Questions?

call 1-888-588-1418

Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA.

Mfg. Lic. No.: 22/RR/AP/2001/F/R

PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride Oral Solution USP, 1 mg/1 mL-container label

Cetirizine Hydrochloride Oral Solution USP, 1 mg/1 mL-carton label

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF

cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69230-316
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69230-316-11	1 in 1 CARTON	03/13/2019
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	ANDA210622	03/13/2019

Labeler - Camber Consumer Care (079539968)

Name	Address	ID/FEI	Business Operations
Establishment
Hetero Labs Limited Unit III		676162024	ANALYSIS(69230-316) , MANUFACTURE(69230-316)

Revised: 3/2019

Document Id: 941e4aa9-6388-424c-87ad-3ea2ec5aafea

Set id: 941e4aa9-6388-424c-87ad-3ea2ec5aafea

Version: 1

Effective Time: 20190315