CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Medline Industries, Inc.

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Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

Cetirizine HCl, USP 10 mg

PURPOSE

Antihistamine

USES

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

  • 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 (1-800-222-1222).

DIRECTIONS

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

Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

QUESTIONS?

Call 1-800-MEDLINE (633-5463), Monday - Friday, 9AM - 5PM CST

PRINCIPAL DISPLAY PANEL

MEDLINE

NDC 53329-652-38

Compare to the active ingredient in Zyrtec®

Original Prescription Strength

CETIRIZINE HCl TABLETS, 10 mg

ANTIHISTAMINE

24 HOUR ALLERGY

Indoor & Outdoor Allergies

Relief of:

SneezingRunny nose

Itchy, Watery EyesItchy Throat or Nose

10 mg

90 TABLETS - 10 mg EACH

Distributed by: Medline Industries, Inc.

5099013/1012

90's bottle carton label.

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53329-652
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
POLYETHYLENE GLYCOLS 
MAGNESIUM STEARATE 
POVIDONE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeRECTANGLE (Rounded Off) Size9mm
FlavorImprint Code R152
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-652-3890 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749812/27/2007
Labeler - Medline Industries, Inc. (025460908)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(53329-652)

Revised: 3/2013
Document Id: 042d252c-843d-4329-8484-97e6e1423d03
Set id: 6823d475-84c6-4d9f-838d-925ccfb96c97
Version: 1
Effective Time: 20130321
 
Medline Industries, Inc.