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NDC 71335-0300-01 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 Bryant Ranch Prepack. 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: 71335-0300-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	71335-0300
Product ID	71335-0300_4b192084-dfdc-47bc-a968-6f49e137b248
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
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	Bryant Ranch Prepack
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA077829
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71335-0300-01 (71335030001)

Pricing Information	N/A
NDC Package Code	71335-0300-1
Billing NDC	71335030001
Package	30 TABLET in 1 BOTTLE (71335-0300-1)
Marketing Start Date	2018-02-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4b192084-dfdc-47bc-a968-6f49e137b248 Details

ACTIVE INGREDIENTS

Active Ingredients (in each tablet) Purpose

Cetirizine HCl USP 10 mg................................................................Antihistimine

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 DOCTOR

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

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

WHEN USING THIS PRODUCT

drowsines may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinary.

STOP USE

Stop use and ask a doctor if an allergic reaction tothis 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 Poison Control Center right away.

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 at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature]

INACTIVE INGREDIENTS

Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

QUESTIONS?

Call 1-844-874-7464

SPL UNCLASSIFIED SECTION

Manufactured by:

Unique Pharmaceutical Labs.

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India

Distributed by:

Rising Pharma holdings, Inc.

East Brunswick, NJ 08816

M. L. G/1430 Jul. 2020

126406

HOW SUPPLIED

NDC: 71335-0300-1: 30 Tablets in a BOTTLE

NDC: 71335-0300-2: 14 Tablets in a BOTTLE

NDC: 71335-0300-3: 7 Tablets in a BOTTLE

NDC: 71335-0300-4: 10 Tablets in a BOTTLE

NDC: 71335-0300-5: 15 Tablets in a BOTTLE

NDC: 71335-0300-6: 90 Tablets in a BOTTLE

NDC: 71335-0300-7: 20 Tablets in a BOTTLE

NDC: 71335-0300-8: 60 Tablets in a BOTTLE

NDC: 71335-0300-9: 100 Tablets in a BOTTLE

PRINCIPAL DISPLAY PANEL

Cetirizine Hcl 10mg Tablet

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE

cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0300(NDC:16571-402)
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (White)	Score	no score
Shape	BULLET (Barrel Shaped)	Size	8mm
Flavor		Imprint Code	CTN;10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-0300-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/16/2018
2	NDC:71335-0300-2	14 in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018
3	NDC:71335-0300-3	7 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
4	NDC:71335-0300-4	10 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2019
5	NDC:71335-0300-5	15 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
6	NDC:71335-0300-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/16/2018
7	NDC:71335-0300-7	20 in 1 BOTTLE; Type 0: Not a Combination Product	03/07/2019
8	NDC:71335-0300-8	60 in 1 BOTTLE; Type 0: Not a Combination Product	10/13/2021
9	NDC:71335-0300-9	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077829	10/01/2009

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0300) , RELABEL(71335-0300)

Revised: 2/2022

Document Id: 4b192084-dfdc-47bc-a968-6f49e137b248

Set id: 4b192084-dfdc-47bc-a968-6f49e137b248

Version: 5

Effective Time: 20220209