CETIRIZINE HYDROCHLORIDE tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)
Available from:
Direct_Rx
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine 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 Stop use and ask a doctor if an allergic reaction tothis product occurs. Seek medical help right away.
Authorization status:
Abbreviated New Drug Application
Authorization number:
61919-538-90

CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet

Direct_Rx

----------

CETIRIZINE HYDROCHLORIDE

Active Ingredients (in each tablet) Purpose

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

Antihistamine

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

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.

drowsines 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 tothis product occurs. Seek medical help right away.

if breast-feeding: not recommended

if pregnant: ask a health professional before use.

In case of overdose, get medical help or contact Poison Control Center right away.

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

store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature]

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

dioxide.

Call 1-866-562-4597

Manufactured by:

Unique Pharmaceutical Labs.

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

Mumbai 400 030, India

Distributed by:

Rising Pharmaceuticals, Inc.

Saddle Brook, NJ 07663

M. L. G/1430 May 2018

120005

CETIRIZINE HYDROCHLORIDE

cetirizine hydrochloride tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 19 19 -538 (NDC:16 571-40 2)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CETIRIZINE HYDRO CHLO RIDE (UNII: 6 4O0 47KTOA) (CETIRIZINE -

UNII:YO726 1ME24)

CETIRIZINE

HYDROCHLORIDE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

STARCH, CO RN (UNII: O8 232NY3SJ)

LACTO SE, UNSPECIFIED FO RM (UNII: J2B2A4N9 8 G)

Dire ct_Rx

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

Product Characteristics

Color

white ((White))

S core

no sco re

S hap e

BULLET ((Barrel Shaped))

S iz e

8 mm

Flavor

Imprint Code

CTN;10

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 19 -538 -9 0

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /14/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 778 29

0 8 /14/20 19

Labeler -

Direct_Rx (079254320)

Registrant -

Direct_Rx (079254320)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dire c t_Rx

0 79 254320

re pa c k(6 19 19 -538 )

Revised: 1/2020

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