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NDC 70000-0047-01 Cetirizine Hydrochloride 10 mg/1 Details

Cetirizine Hydrochloride 10 mg/1

Cetirizine Hydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. 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: 70000-0047-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	70000-0047
Product ID	70000-0047_3516544d-5a68-417f-be0e-47914dd86b38
Associated GPIs	41550020100320
GCN Sequence Number	017037
GCN Sequence Number Description	cetirizine HCl TABLET 10 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	49291
HICL Sequence Number	006544
HICL Sequence Number Description	CETIRIZINE HCL
Brand/Generic	Generic
Proprietary Name	Cetirizine Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Cetirizine Hydrochloride Allergy
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	Cardinal Health
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 70000-0047-01 (70000004701)

Pricing Information
NDC Package Code	70000-0047-1
Billing NDC	70000004701
Package	365 TABLET in 1 BOTTLE (70000-0047-1)
Marketing Start Date	2020-03-26
NDC Exclude Flag	N
Price Per Unit	0.06399
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	ALL DAY ALLERGY 10 MG TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 0cab7aa8-ded3-46f1-b801-2663cc9b0173 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?

call 1-855-274-4122

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Made in India

Code: TS/DRUGS/19/1993

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (365's Tablets Bottle)

LEADERTM

NDC 70000-0047-1

Original Prescription Strength

All Day Allergy

Cetirizine Hydrochloride Tablets

USP, 10 mg | Antihistamine

COMPARE TO

ZYRTEC®

active ingredient*

Indoor and

Outdoor Allergies

24-Hour Relief of:

Sneezing; Runny Nose; Itchy,

Watery Eyes; Itchy Throat or Nose

365 TABLETS

10 mg EACH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (14's Tablet Blister Pack Label)

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE

cetirizine hydrochloride allergy tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0047
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	Marketing End Date
Packaging
1	NDC:70000-0047-1	365 in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090760	03/26/2020

Labeler - Cardinal Health (063997360)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		918917642	ANALYSIS(70000-0047) , MANUFACTURE(70000-0047)

Revised: 6/2021

Document Id: 3516544d-5a68-417f-be0e-47914dd86b38

Set id: 0cab7aa8-ded3-46f1-b801-2663cc9b0173

Version: 3

Effective Time: 20210616