CETIRIZINE - cetirizine hydrochloride tablet 
Life Line Home Care Services, Inc.

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Cetirizine HCL 10mg Tablet

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 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

6 years and over

adults and children

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

Other information


Inactive ingredients


Hypromellose, lactose, magnesium, stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

Cetirizine HCL 10mg Tablet

CETIRIZINE HCL (Cetirizine Hydrochloride) Tablets

10 MG

Cetirizine 10mg Label Image

CETIRIZINE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75921-402(NDC:16571-402)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeBULLET (Barrel Shaped) Size8mm
FlavorImprint Code CTN;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75921-402-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782902/03/2012
Labeler - Life Line Home Care Services, Inc. (844985374)
Establishment
NameAddressID/FEIBusiness Operations
Life Line Home Care Services, Inc.844985374REPACK, RELABEL

Revised: 2/2012
Document Id: b95a1e89-9d39-4267-af6f-3a8642043685
Set id: df5f520a-9d1f-4b56-971c-cfb46416750f
Version: 1
Effective Time: 20120203
 
Life Line Home Care Services, Inc.