CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Lake Erie Medical DBA Quality Care Products LLC

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Cetirizine Hydrochloride Tablets, 10 mg, Allergy

Active Ingredients

Cetirizine HCl 10 mg..............................................................................................Antihistimine Active Ingredients (in each tablet)                                                        Purpose

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

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Do Not Use

liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor before use if you have

taking tranquilizers or sedatives. Ask a doctor or pharmacist before use if you are

When using this product

if an allergic reaction to this product occurs. Seek medical help right away. Stop use and ask a doctor

If pregnant or breast-feeding:

Keep out of reach of children.

In case of overdose, get medical help or contact Poison Control Center right away.

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 sever 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

Inactive Ingredients

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

Manufactured for PACK Pharmaceuticals, LLC Buffalo Grove, IL 60089, USA

Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India

image description

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55700-331(NDC:16571-401)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) Cetirizine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
hypromelloses (UNII: 3NXW29V3WO)  
lactose (UNII: J2B2A4N98G)  
magnesium stearate (UNII: 70097M6I30)  
starch, corn (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size7mm
FlavorImprint Code CTN;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55700-331-3030 in 1 BOTTLE; Type 0: Not a Combination Product07/24/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782910/01/2009
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIBusiness Operations
Lake Erie Medical DBA Quality Care Products LLC831276758repack(55700-331)

Revised: 9/2019
Document Id: 72ed3b32-d2fb-44bc-af1f-f610db82ef45
Set id: 1f21e5f0-0475-425b-9165-7f1456435ba1
Version: 2
Effective Time: 20190918
 
Lake Erie Medical DBA Quality Care Products LLC