CETIRIZINE HYDROCHLORIDE

Main information

  • Trade name:
  • CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, film coated
  • Composition:
  • CETIRIZINE HYDROCHLORIDE 5 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, film coated
    United States
  • Language:
  • English

Therapeutic information

  • 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

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 54868-5855-0
  • Last update:
  • 30-05-2019

Summary of Product characteristics: dosage, interactions, side effects

CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, film coated

Physicians Total Care, Inc.

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Drug Facts

Active ingredient

Cetirizine Hydrochloride 5 mg

Purpos e

Antihistamine

Us es

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.

Directions

adults and children

6 years and over

1 to 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

Other information

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

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline

cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

Ques tions ?

call 1-877-446-3679

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505

PRINCIPAL DISPLAY PANEL - 5 mg Hives Relief

NDC 54868-5855-0

Cetirizine Hydrochloride

Tablets 5 mg

antihistamine

24

HOUR

Relief of

ITCHING

Due to Hives

Tamper Evident: do not use if foil seal under cap

is missing, open or broken

CETIRIZINE HYDROCHLORIDE

cetirizine hydrochloride tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:548 6 8 -58 55(NDC:0 378 -36 35)

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

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

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

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYDEXTRO SE (UNII: VH2XOU12IE)

PO LYETHYLENE GLYCO LS (UNII: 3WJQ0 SDW1A)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

6 mm

Flavor

Imprint Code

M;C35

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:548 6 8 -58 55-0

10 0 in 1 BOTTLE, PLASTIC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 6 77

0 1/29 /20 0 8

Physicians Total Care, Inc.

Labeler -

Physicians T otal Care, Inc. (194123980)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Physicians To tal Care, Inc.

19 41239 8 0

re la be l

Revised: 5/2012