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NDC 50269-0014-01 Zyrtec 1s Blister 10 mg/1 Details

Zyrtec 1s Blister 10 mg/1

Zyrtec 1s Blister is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by JC World Bell Wholesale Co., 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: 50269-0014-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	50269-0014
Product ID	50269-014_dc783f6a-05e5-1b8f-e053-2995a90a2f05
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	Zyrtec 1s Blister
Proprietary Name Suffix	n/a
Non-Proprietary Name	CETIRIZINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	CETIRIZINE HYDROCHLORIDE
Labeler Name	JC World Bell Wholesale Co., Inc.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA019835
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50269-0014-01 (50269001401)

Pricing Information	N/A
NDC Package Code	50269-014-01
Billing NDC	50269001401
Package	6 BLISTER PACK in 1 BOX (50269-014-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2019-01-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3a595eb8-2409-4598-8704-ab59b57bd062 Details

Drug Facts

Active ingredient ((in each tablet))

Cetrizine HCl 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 kidny 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 reastion 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 10mg tablet once daily; do not take more than one 10mg tabelt 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)
do not use if pouch is torn or damaged
meets USP Dissolution Test 2

Inactive ingredients

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

Questions?

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

Package Labeling:

INGREDIENTS AND APPEARANCE

ZYRTEC 1S BLISTER

cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50269-014(NDC:50580-726)
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, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	2 pieces
Shape	RECTANGLE	Size	9mm
Flavor		Imprint Code	ZYRTEC;10;MG
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50269-014-01	6 in 1 BOX	01/20/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019835	01/20/2019

Labeler - JC World Bell Wholesale Co., Inc. (805257581)

Name	Address	ID/FEI	Business Operations
Establishment
JC World Bell Wholesale Co., Inc.		805257581	repack(50269-014)

Name	Address	ID/FEI	Business Operations
Establishment
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division		878046358	manufacture(50269-014)

Revised: 4/2022

Document Id: dc783f6a-05e5-1b8f-e053-2995a90a2f05

Set id: 3a595eb8-2409-4598-8704-ab59b57bd062

Version: 2

Effective Time: 20220412