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NDC 58602-0716-16 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: 58602-0716-16
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	58602-0716
Product ID	58602-716_1bbefda2-d3c5-4d31-b3ec-7da077e41157
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 58602-0716-16 (58602071616)

Pricing Information	N/A
NDC Package Code	58602-716-16
Billing NDC	58602071616
Package	1 BOTTLE in 1 CARTON (58602-716-16) / 65 CAPSULE in 1 BOTTLE
Marketing Start Date	2022-08-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1bbefda2-d3c5-4d31-b3ec-7da077e41157 Details

SPL UNCLASSIFIED SECTION

Cetirizine HCl Capsules 10 mg (Allergy)

Drug Facts

Active ingredient (in each capsule)

Cetirizine HCI USP 10 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.

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

SPL UNCLASSIFIED SECTION

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

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

store at 20°-25°C (68°-77°F)
avoid high humidity and excessive heat above 40°C (104°F)
protect from light
do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.

Inactive ingredients

gelatin, glycerin, polyethylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution

Questions or comments?

call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (65's Capsule Container Label)

Healthy LivingTM

Allergy                         Original Prescription Strength

CETIRIZINE HCl

Capsules 10 mg

Antihistamine

Indoor + Outdoor Allergies

READ AND KEEP THE OUTER PACKAGE FOR            65 LIQUID GELS*

COMPLETE WORNINGS AND INFORMATION          *liquid-filled capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (65's Capsule Container Carton Label)

Healthy LivingTM

Allergy Original Prescription Strength

CETIRIZINE HCl

Capsules 10 mg

Antihistamine

Indoor + Outdoor Allergies                            *Compare

                                                                     to the Active

                                                                     Ingredient in                  CZ10

                                                                        Zyrtec®                             (Actual Size)

24 Hour Relief of: • Sneezing • Runny Nose                      65 Liquid Gels*

• Itchy, Watery Eyes • Itchy Throat or Nose                     *liquid-filled capsules

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE (ALLERGY)

cetirizine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58602-716
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	YELLOW (Clear colourless to pale yellow viscous liquid)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	CZ10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58602-716-16	1 in 1 CARTON	08/16/2022
1		65 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	ANDA209107	08/16/2022

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
APL HEALTHCARE LIMITED		650844777	ANALYSIS(58602-716) , MANUFACTURE(58602-716)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-716) , MANUFACTURE(58602-716)

Revised: 8/2022

Document Id: 1bbefda2-d3c5-4d31-b3ec-7da077e41157

Set id: 1bbefda2-d3c5-4d31-b3ec-7da077e41157

Version: 1

Effective Time: 20220816

Search by Drug Name or NDC

NDC 58602-0716-16 Cetirizine Hydrochloride (Allergy) 10 mg/1 Details

Cetirizine Hydrochloride (Allergy) 10 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 58602-0716-16 (58602071616)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 1bbefda2-d3c5-4d31-b3ec-7da077e41157 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each capsule)

Purpose

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

Other information

Inactive ingredients

Questions or comments?

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (65's Capsule Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (65's Capsule Container Carton Label)

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