Search by Drug Name or NDC

NDC 63868-0865-04 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 C.D.M.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: 63868-0865-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	63868-0865
Product ID	63868-865_434f1b5b-1e26-406a-a5e2-df310b74e993
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 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	C.D.M.A., Inc.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090750
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0865-04 (63868086504)

Pricing Information	N/A
NDC Package Code	63868-865-04
Billing NDC	63868086504
Package	1 BOTTLE in 1 CARTON (63868-865-04) / 120 mL in 1 BOTTLE
Marketing Start Date	2014-11-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b4feed95-86ca-411c-99b5-773e485e752f Details

Active ingredient (in each 5 mL teaspoonful)

Cetirizine Hydrochloride USP 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.

Directions

use only with enclosed dosing cup

adults and children 6 years and over	1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and over	1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age	1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (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)

Inactive ingredients

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

Questions?

call 248-449-9300

Distributed by:

C.D.M.A, Inc.©

43157 W.Nine Mile

Novi.MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

PACKAGE LABEL- PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL Bottle)

NDC 63868-865-04

*Compare to the

active ingredient in

Children's ZYRTEC®

Children's

Allergy

Relief

Indoor & Outdoor

Allergies

Cetirizine Hydrochloride

Oral Solution, USP 1mg/mL

Antihistamine

For Relief of:

Runny Nose | Sneezing

Itchy, Watery Eyes |

Itchy Nose or Throat

2 yrs. & older

Grape

Flavor

Dosing Cup

Included

4 FL OZ (120 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF

cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-865
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 (UNII: 4550K0SC9B)
SUCROSE (UNII: C151H8M554)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-865-04	1 in 1 CARTON	11/20/2014
1		120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090750	11/20/2014

Labeler - C.D.M.A., Inc. (011920774)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		918917642	MANUFACTURE(63868-865)

Revised: 12/2020

Document Id: 434f1b5b-1e26-406a-a5e2-df310b74e993

Set id: b4feed95-86ca-411c-99b5-773e485e752f

Version: 4

Effective Time: 20201213