CETIRIZINE HCL 10 MG ALL DAY ALLERGY RELIEF- cetirizine hydrochloride tablet 
Freds Inc

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DRUG FACTS

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:

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 reation 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 table 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information

Inactive ingredients

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

Questions or comments?

Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

All Day Allergy Relief

Cetirizine HCl, 10 mg Tablets

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of

Runny Nose

Sneezing

Itchy, Watery Eyes

Itchy Throat or Nose

Tablets

Compare to the active ingredient in Zyrtec®**

**This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Zyrtec®.

Product of USA

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL RD, MEMPHIS, TN  38118

www.fredsinc.com

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

Cetirizine HCL 10 mg Tablet

Fred's All Day Allergy Relief Tablets

 

CETIRIZINE HCL 10 MG ALL DAY ALLERGY RELIEF 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55315-129
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 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONES 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code IP46
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-129-302 in 1 CARTON
115 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07878003/01/2013
Labeler - Freds Inc (005866116)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 2/2013
Document Id: fabe236f-5194-4c54-ae74-1378b176f2bb
Set id: d09f9fde-dfcd-40e8-8ba6-3435cc73e353
Version: 2
Effective Time: 20130214
 
Freds Inc