Your browser does not support JavaScript! CETIRIZINE HYDROCHLORIDE TABLET [TOPCO ASSOCIATES LLC]
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CETIRIZINE HYDROCHLORIDE tablet
[Topco Associates LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

ACTIVE INGREDIENT (IN EACH CAPLET)

Cetirizine HCl, 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 (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

  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F)

INACTIVE INGREDIENTS

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

QUESTIONS?

Call 1-888-423-0139

PRINCIPAL DISPLAY PANEL

TopCare®

NDC 36800-244-18

ORIGINAL PRESCRIPTION STRENGTH

All Day Allergy

CETIRIZINE HCl TABLETS, 10 mg

ANTIHISTAMINE

24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Indoor & Outdoor Allergies

5 TABLETS

10 mg EACH

COMPARE TO ZYRTEC®

active ingredient*

Distributed by: TOPCO ASSOCIATES LLC

5099010/1012

This is the 5 count blister carton label for TopCare Cetirizine HCl tablets, 10 mg.
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:36800-244
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 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
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:36800-244-185 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749812/27/2007
Labeler - Topco Associates LLC (006935977)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(36800-244)

Revised: 11/2012
 
Topco Associates LLC

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