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Cetirizine Hydrochloride by Aidarex Pharmaceuticals LLC

Medically reviewed on Sep 17, 2018

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Aidarex Pharmaceuticals LLC
NDC Code: 33261-393

Cetirizine Hydrochloride Tablets, 10 mg, Allergy

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

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

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 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

Other Information

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

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

Questions?

Call 1-866-562-4597

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 \

Repackaged By:
Aidarex Pharmaceuticals, LLC.
Corona, CA 92880

Cetirizine Hydrochloride Tablets 10 mg Container Label

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33261-393(NDC:16571-402)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 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) Size8mm
FlavorImprint CodeCTN;10
Contains    
Packaging
#Item CodePackage Description
1NDC:33261-393-1010 TABLET (10 TABLET) in 1 BOTTLE
2NDC:33261-393-1414 TABLET (14 TABLET) in 1 BOTTLE
3NDC:33261-393-2020 TABLET (20 TABLET) in 1 BOTTLE
4NDC:33261-393-3030 TABLET (30 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782910/01/2009
Labeler - Aidarex Pharmaceuticals LLC (801503249)

 
Aidarex Pharmaceuticals LLC

← See all Cetirizine Hydrochloride brands

Further information

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

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