Your browser does not support JavaScript! CETIRIZINE HYDROCHLORIDE (CETIRIZINE) TABLET [RUGBY LABORATORIES INC]
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RxNorm Names

CETIRIZINE HYDROCHLORIDE (cetirizine) tablet
[Rugby Laboratories Inc]


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

Active Ingredient (in each tablet)

Cetirizine HCl 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

Adults and children 6 years and overtake 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 between 20 to 25°C (68 to 77°F)

Inactive Ingredients

lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc, titanium dioxide.

Questions or comments?

Call 1-800-645-2158, 9am-5pm ET. Monday-Friday

Principal Display Panel

Compare to Active Ingredient in ZYRTEC®*

Original Prescription Strength

CETIRIZINE HYDROCHLORIDE TABLETS, 10 mg

ANTIHISTAMINE

ALLERGY

Indoor and Outdoor Allergies

24 hour relief of:

  • Runny nose
  • Sneezing
  • Itchy, watery eyes
  • Itchy throat or nose

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

*Rugby Laboratories is not affiliated with the owner of the trademark Zyrtec®.

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150

www.rugbylaboratories.com

Product Label

Cetirizine 10 mg

Rugby Cetirizine 10 mg Allergy Tablet



CETIRIZINE HYDROCHLORIDE 
cetirizine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-4088
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYVINYL ALCOHOL 
POLYETHYLENE GLYCOLS 
POVIDONES 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (white) Scoreno score
ShapeOVAL (oval) Size8mm
FlavorImprint Code IP;46
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-4088-114 in 1 BOX
190 in 1 BLISTER PACK
2NDC:0536-4088-881 in 1 BOX
214 in 1 BLISTER PACK
3NDC:0536-4088-072 in 1 BOX
330 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07878003/23/2012
Labeler - Rugby Laboratories Inc (191427277)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 4/2013
 
Rugby Laboratories Inc

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