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Cetirizine Hydrochloride by Cardinal Health

Dosage form: tablet, film coated
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Cardinal Health
NDC Code: 55154-5399

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.

Available overbagged with 10 tablets per bag, NDC 55154-5399-0.

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.

Repackaged By:

Cardinal Health

Zanesville, OH 43701

L48853560617

S-9827 R8
1/17

Principal Display Panel

Cetirizine HCl Tablets, USP

10 mg

10 Tablets

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-5399(NDC:51079-597)
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:55154-5399-010 BLISTER PACK in 1 BAG
11 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07667703/30/2012
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-5399)

 
Cardinal Health

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Medically reviewed on Jun 23, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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