CETIRIZINE HYDROCHLORIDE tablet

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

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Active ingredient:
Active Ingredients (in each tablet)                                                Purpose, Cetirizine HCl USP 10 mg................................................................Antihistimine
Available from:
Bryant Ranch Prepack
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:
63629-8041-1

CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet

Bryant Ranch Prepack

----------

Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy

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

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 1-866-562-4597

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

CETRIZINE HCL 10MG TABLET

CETIRIZINE HYDROCHLORIDE

cetirizine hydrochloride tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 36 29 -8 0 41(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 SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

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

ma g nesium stea ra te (UNII: 70 0 9 7M6 I30 )

sta rch, co rn (UNII: O8 232NY3SJ)

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

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

tita nium dio xide (UNII: 15FIX9 V2JP)

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

Bryant Ranch Prepack

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 36 29 -8 0 41-1

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/18 /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

10 /0 1/20 0 9

Labeler -

Bryant Ranch Prepack (171714327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bryant Ranch Prepack

171714327

REPACK(6 36 29 -8 0 41) , RELABEL(6 36 29 -8 0 41)

Revised: 8/2019

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