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Cetirizine Hydrochloride by Mylan Institutional Inc.

Dosage form: tablet, film coated
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Mylan Institutional Inc.
NDC Code: 51079-597

Drug Facts

CETIRIZINE HCl
10 mg TABLETS, USP

Antihistamine

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

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

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
  • Serious side effects associated with use of this product may be
    reported to this number.

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.

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

Antihistamine

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

  • 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.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51079-597(NDC:0378-3637)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeM;C37
Contains    
Packaging
#Item CodePackage Description
1NDC:51079-597-20100 BLISTER PACK in 1 BOX, UNIT-DOSE
1NDC:51079-597-011 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07667703/30/2012
Labeler - Mylan Institutional Inc. (039615992)

Revised: 03/2017
 
Mylan Institutional Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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