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NDC 30142-0172-54 Cetirizine Hydrochloride (Allergy) 10 mg/1 Details

Cetirizine Hydrochloride (Allergy) 10 mg/1

Cetirizine Hydrochloride (Allergy) is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by KROGER COMPANY. 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: 30142-0172-54
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	30142-0172
Product ID	30142-172_38264bca-705b-4ca5-8387-ad60736a2eb8
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	TABLET
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	CETIRIZINE HYDROCHLORIDE
Labeler Name	KROGER COMPANY
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090760
Listing Certified Through	2024-12-31

Package

Package Images

NDC 30142-0172-54 (30142017254)

Pricing Information	N/A
NDC Package Code	30142-172-54
Billing NDC	30142017254
Package	1 BOTTLE in 1 CARTON (30142-172-54) / 70 TABLET in 1 BOTTLE
Marketing Start Date	2021-03-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b92d959d-dd35-b2a3-e053-2995a90af3ff Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Cetirizine hydrochloride 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.

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

adults and children 6 years and over	one 10 mg tablet once daily; do not take more than one 10 mg tablet 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 between 20° to 25°C (68° to 77°F)
TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions?

1-800-632-6900

DISTRIBUTED BY

THE KROGER CO.

CINCINNATI,

OHIO 45202

MADE IN INDIA

Code: TS/DRUGS/19/1993

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Label)

NDC 30142-172-09

KROGER®

ORIGINAL

PRESCRIPTION STRENGTH

ALLERGY

Cetirizine

Hydrochloride

Tablets USP 10 mg

Antihistamine

24

HOUR

30 TABLETS

10 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)

COMPARE TO the active ingredient of ZYRTEC®*See side panel

KROGER® NDC 30142-172-09

ORIGINAL PRESCRIPTION STRENGTH

ALLERGY

Cetirizine Hydrochloride

Tablets USP 10 mg

Antihistamine

INDOOR & OUTDOOR

ALLERGIES

actual

size

24

HOUR

RELIEF OF:

Sneezing;

Runny Nose;

Itchy, Watery Eyes;

Itchy Throat or Nose

30 TABLETS

10 mg each

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE (ALLERGY)

cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-172
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	X;36
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:30142-172-09	1 in 1 CARTON	03/15/2021
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:30142-172-54	1 in 1 CARTON	03/15/2021
2		70 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	ANDA090760	03/15/2021

Labeler - KROGER COMPANY (006999528)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		918917642	ANALYSIS(30142-172) , MANUFACTURE(30142-172)

Revised: 4/2021

Document Id: 38264bca-705b-4ca5-8387-ad60736a2eb8

Set id: b92d959d-dd35-b2a3-e053-2995a90af3ff

Version: 3

Effective Time: 20210415