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NDC 49483-0682-01 Cetirizine Hydrochloride 5 mg/1 Details

Cetirizine Hydrochloride 5 mg/1

Cetirizine Hydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by TIME CAP 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: 49483-0682-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	49483-0682
Product ID	49483-682_dfbdaf6a-c5e8-c5f9-e053-2995a90ae2c6
Associated GPIs	41550020100310
GCN Sequence Number	024484
GCN Sequence Number Description	cetirizine HCl TABLET 5 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	49292
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	5
Active Ingredient Units	mg/1
Substance Name	CETIRIZINE HYDROCHLORIDE
Labeler Name	TIME CAP LABORATORIES, INC.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA078933
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49483-0682-01 (49483068201)

Pricing Information
NDC Package Code	49483-682-01
Billing NDC	49483068201
Package	100 TABLET in 1 BOTTLE (49483-682-01)
Marketing Start Date	2022-05-30
NDC Exclude Flag	N
Price Per Unit	0.04849
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	ALLERGY RLF (CETRZN) 5 MG TAB
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 dfbddafb-9455-5805-e053-2a95a90ad0d9 Details

DRUG FACTS

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Cetirizine HCl 5 mg

SPL UNCLASSIFIED SECTION

Purpose

Antihistamine

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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).

SPL UNCLASSIFIED SECTION

Directions

adults and children 6 years and over	1 or 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over	1 tablet once a day; do not take more than 1 tablet in 24 hours.
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

SPL UNCLASSIFIED SECTION

Other information

• store between 20° to 25°C (68° to 77°F).

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Questions or comments?

Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE

cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49483-682
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Product Characteristics
Color	white (White to off white)	Score	no score
Shape	RECTANGLE (Rounded-off rectangular shaped)	Size	7mm
Flavor		Imprint Code	J;219
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49483-682-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/30/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078933	05/30/2022

Labeler - TIME CAP LABORATORIES, INC. (037052099)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
MARKSANS PHARMA LIMITED		925822975	manufacture(49483-682)

Revised: 5/2022

Document Id: dfbdaf6a-c5e8-c5f9-e053-2995a90ae2c6

Set id: dfbddafb-9455-5805-e053-2a95a90ad0d9

Version: 1

Effective Time: 20220524

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NDC 49483-0682-01 Cetirizine Hydrochloride 5 mg/1 Details

Cetirizine Hydrochloride 5 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 49483-0682-01 (49483068201)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL dfbddafb-9455-5805-e053-2a95a90ad0d9 Details

DRUG FACTS

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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