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Cetirizine Hydrochloride by Lake Erie Medical DBA Quality Care Products LLC

Medically reviewed on November 21, 2016

Dosage form: tablet
Ingredients: Cetirizine Hydrochloride 5mg
Labeler: Lake Erie Medical DBA Quality Care Products LLC
NDC Code: 55700-331

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
  • drowsines may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinary.

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

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 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

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55700-331(NDC:16571-401)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (CETIRIZINE) Cetirizine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
hypromelloses 
lactose 
magnesium stearate 
starch, corn 
POLYETHYLENE GLYCOLS 
POVIDONES 
titanium dioxide 
Product Characteristics
Colorwhite (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size7mm
FlavorImprint CodeCTN;5
Contains    
Packaging
#Item CodePackage Description
1NDC:55700-331-3030 TABLET in 1 BOTTLE
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/FEIOperations
Lake Erie Medical DBA Quality Care Products LLC831276758repack(55700-331)

 
Lake Erie Medical DBA Quality Care Products LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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