Search by Drug Name or NDC

NDC 51660-0939-53 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 Ohm Laboratories Inc.. 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: 51660-0939-53
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	51660-0939
Product ID	51660-939_2a87ee90-da59-4e35-9cda-27759ba080d4
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	Ohm Laboratories Inc.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA077498
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51660-0939-53 (51660093953)

Pricing Information	N/A
NDC Package Code	51660-939-53
Billing NDC	51660093953
Package	300 TABLET in 1 BOTTLE (51660-939-53)
Marketing Start Date	2007-12-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 161c4122-2c89-46e6-a6ae-db088087330d Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl, 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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
store between 20° to 25° C (68° to 77° F)

Inactive ingredients

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

Questions?

call 1-800-406-7984

SPL UNCLASSIFIED SECTION

Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC 51660-939-53

†Compare To

the active ingredient of

Zyrtec®

ohm®

Allergy Relief

Cetirizine HCl Tablets, USP 10 mg

ANTIHISTAMINE

Indoor & Outdoor Allergies

24 Hour Relief of:

• Sneezing • Runny Nose

• Itchy, Watery Eyes • Itchy Throat or Nose

300 TABLETS

10 mg EACH

24

Hours

Original Prescription Strength

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE

cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51660-939
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
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white	Score	no score
Shape	RECTANGLE (rounded-off)	Size	9mm
Flavor		Imprint Code	RI52
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51660-939-54	14 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/27/2007
2	NDC:51660-939-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007
3	NDC:51660-939-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007
4	NDC:51660-939-13	120 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007
5	NDC:51660-939-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007
6	NDC:51660-939-53	300 in 1 BOTTLE; Type 0: Not a Combination Product	12/27/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077498	12/27/2007

Labeler - Ohm Laboratories Inc. (184769029)

Registrant - Sun Pharmaceutical Industries Inc. (146974886)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		184769029	MANUFACTURE(51660-939)

Revised: 5/2021

Document Id: 2a87ee90-da59-4e35-9cda-27759ba080d4

Set id: 161c4122-2c89-46e6-a6ae-db088087330d

Version: 8

Effective Time: 20210521

Search by Drug Name or NDC

NDC 51660-0939-53 Cetirizine Hydrochloride 10 mg/1 Details

Cetirizine Hydrochloride 10 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 51660-0939-53 (51660093953)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 161c4122-2c89-46e6-a6ae-db088087330d Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Purpose

Uses

Warnings

When using this product

If pregnant or breast-feeding

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

INGREDIENTS AND APPEARANCE

Migranal Generic Name Question

Can You Take A Z-Pak If You Have A Penicillin Allergy?