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NDC 58602-0806-53 Cetirizine Hydrochloride (Allergy) 10 mg/1 Details
Cetirizine Hydrochloride (Allergy) 10 mg/1
Cetirizine Hydrochloride (Allergy) is a ORAL CAPSULE 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: 58602-0806-53Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine
Product Information
NDC | 58602-0806 |
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Product ID | 58602-806_926879b5-84de-436c-b0ed-3310c07b8523 |
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 | Cetirizine Hydrochloride (Allergy) |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Cetirizine Hydrochloride |
Product Type | HUMAN OTC DRUG |
Dosage Form | CAPSULE |
Route | ORAL |
Active Ingredient Strength | 10 |
Active Ingredient Units | mg/1 |
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 | ANDA209107 |
Listing Certified Through | 2024-12-31 |
Package
Package Images


NDC 58602-0806-53 (58602080653)
NDC Package Code | 58602-806-53 |
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Billing NDC | 58602080653 |
Package | 1 BOTTLE in 1 CARTON (58602-806-53) / 25 CAPSULE in 1 BOTTLE |
Marketing Start Date | 2018-07-20 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ffbca2a4-8df0-4c85-adf9-9414cd706fb2 Details
Uses
Warnings
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding:
Keep out of reach of children.
Directions
adults and children 6 years and over | one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms. |
adults 65 years and over | ask a doctor |
children under 6 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
Other information
Inactive ingredients
Questions or comments?
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12's Capsule Container Carton Label)
NDC 58602-806-04
*Compare to the active ingredient in Zyrtec®
Original Prescription Strength
ALLERGY
Cetirizine HCl Capsules
10 mg
Antihistamine
INDOOR +OUTDOOR CZ10
ALLERGIES (Actual Size)
24 HOUR
RELIEF OF
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
12 LIQUID GELS*
* LIQUID-FILLED CAPSULES
AUROHEALTH
INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE (ALLERGY)
cetirizine hydrochloride capsule |
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Labeler - Aurohealth LLC (078728447) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
APL HEALTHCARE LIMITED | 650844777 | ANALYSIS(58602-806) , MANUFACTURE(58602-806) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Aurobindo Pharma Limited | 650381903 | ANALYSIS(58602-806) , MANUFACTURE(58602-806) |