CETIRIZINE HYDROCHLORIDE

Main information

  • Trade name:
  • CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated
  • Composition:
  • CETIRIZINE HYDROCHLORIDE 10 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:
  • Product summary:
  • Cetirizine Hydrochloride Tablets, USP are available as follows: 10 mg - White, film-coated, round, biconvex, beveled edge, unscored tablets debossed with M on one side of the tablet and C37 on the other side. NDC 51079-597-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-9827 R8 1/17

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 51079-597-01, 51079-597-20
  • Last update:
  • 23-06-2019

Summary of Product characteristics: dosage, interactions, side effects

CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated

Mylan Institutional Inc.

----------

Drug Facts

CETIRIZINE HCl

10 mg TABLETS, USP

Antihis tamine

Indoor & Outdoor Allergies

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN,

BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Active ingredient (in each tablet)

Cetirizine Hydrochloride, USP 10 mg

Purpos e

Antihistamine

Us es

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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

runny nose

sneezing

itchy, watery eyes

itching of the nose or throat

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:

Keep out of reach of children.

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

Directions (24 Hour Relief)

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

Other information

Inactive ingredients

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

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

Questions? 1-800-848-0462

HOW SUPPLIED

Cetirizine Hydrochloride Tablets, USP are available as follows:

10 mg - White, film-coated, round, biconvex, beveled

edge, unscored tablets debossed with M on one side of

the tablet and C37 on the other side.

NDC 51079-597-20 - Unit dose blister packages

of 100 (10 cards of 10 tablets each).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Manufactured by:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

if breast-feeding: not recommended

if pregnant: ask a health professional before use.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Serious side effects associated with use of this product may be

reported to this number.

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

S-9827 R8

1/17

PRINCIPAL DISPLAY PANEL - 10 mg

NDC 51079-597-20

Cetirizine HCl

Tablets, USP

10 mg

Antihis tamine

Indoor & Outdoor Allergies

24 Hour Relief

(See Uses section of enclosed leaflet)

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE

TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Manufactured by:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

S-9828 R6

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

CETIRIZINE HYDROCHLORIDE

cetirizine hydrochloride tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:510 79 -59 7(NDC:0 378 -36 37)

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

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

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

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYDEXTRO SE (UNII: VH2XOU12IE)

PO LYETHYLENE GLYCO L, UNSPECIFIED (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

8 mm

Flavor

Imprint Code

M;C37

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:510 79 -59 7-20

10 0 in 1 BOX, UNIT-DOSE

0 3/30 /20 12

1

NDC:510 79 -59 7-0 1

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

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 3/30 /20 12

Labeler -

Mylan Institutional Inc. (039615992)

Mylan Institutional Inc.

Revised: 1/2017