Search by Drug Name or NDC
NDC 58602-0422-20 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 Aurohealth LLC. 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: 58602-0422-20Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine
Product Information
| NDC | 58602-0422 |
|---|---|
| Product ID | 58602-422_2775dfed-a43a-4ecd-b8ff-e8de3b839a34 |
| 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 | Aurohealth LLC |
| 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 58602-0422-20 (58602042220)
| NDC Package Code | 58602-422-20 |
|---|---|
| Billing NDC | 58602042220 |
| Package | 1 BOTTLE in 1 CARTON (58602-422-20) / 240 mL in 1 BOTTLE |
| Marketing Start Date | 2010-02-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 52dc28ac-4059-4b6c-8bbc-22aa479a549a Details
Drug Facts
Uses
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.
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.
Directions
- use only with enclosed dosing cup
- find right dose on chart below
- mL=milliliter
| 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 | ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ 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
Inactive ingredients
Questions?
call 1-855-274-4122
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's ZYRTEC® Allergy Syrup. Children's ZYRTEC® Allergy Syrup is a registered trademark of UCB Pharma, S.A. Corporation Belgium
Dosing cup should be washed and left to air dry after each use.
Do not use if carton is opened, or if cap safety seal is broken or missing.
Distributed by: AUROHEALTH LLC,
2572 Brunswick Pike,
Lawrenceville, NJ 08648
a division of Aurobindo Pharma USA, Inc.
6 Wheeling Road, Dayton NJ 08810
Made in INDIA
Code: TS/DRUGS/19/1993
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL (120 mL Bottle)
AUROHEALTH
NDC 58602-422-12
*Compare to active ingredient in Children's ZYRTEC®Allergy Syrup
Children's Allergy Relief
Cetirizine Hydrochloride Oral Solution USP 1 mg/mL
antihistamine
Indoor & Outdoor Allergies
24 hour relief of:
- Sneezing
- Runny nose
- Itchy, watery eyes
- Itchy nose or throat
Dye Free Grape Syrup
4 fl oz (120 mL) 2 yrs. & older
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)
AUROHEALTH
NDC 58602-422-12
*Compare to active ingredient in Children’s ZYRTEC® Allergy Syrup
Children's Allergy Relief
Cetirizine Hydrochloride Oral Solution USP
1 mg/mL
antihistamine
Indoor & Outdoor Allergies
24 hour Relief of
- Sneezing
- Runny nose
- Itchy, watery eyes
- Itchy nose or throat
2 yrs. & older
Dye-Free Grape Syrup
4 fl oz (120 mL) Dosing Cup Included
INGREDIENTS AND APPEARANCE
| CHILDRENS ALLERGY RELIEF
cetirizine hydrochloride solution |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| Labeler - Aurohealth LLC (078728447) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Aurobindo Pharma Limited | 918917642 | ANALYSIS(58602-422) , MANUFACTURE(58602-422) | |