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Allergy Relief by International Laboratories, LLC

Medically reviewed on April 6, 2017

Dosage form: tablet, film coated
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: International Laboratories, LLC
NDC Code: 54458-859

International Laboratories, Inc. Allergy Relief 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:

  • 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
  • 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. (1-800-222-1222)

Directions
adults and children 6 years and overone 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
  • store between 20 to 25ºC (68 to 77ºF)

Inactive ingredients

corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

Questions or comments?

 1-800-579-1868

PRINCIPAL DISPLAY PANEL

Drug Facts Label

Drug Facts

 

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Zyrtec® Tablets

Indoor & Outdoor Allergies

Original Prescription Strength

Allergy Relief

CETIRIZINE HYDROCHLORIDE TABLETS, 10 mg

Antihistamine

24 hour relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

24 HOUR

5 TABLETS 

Actual Size

LIFT HERE TO OPEN

Cetirizine 10mg Allergy Relief

 

ALLERGY RELIEF 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54458-859(NDC:59779-458)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYDEXTROSE 
POVIDONE 
TITANIUM DIOXIDE 
TRIACETIN 
POLYETHYLENE GLYCOLS 
HYPROMELLOSES 
FD&C BLUE NO. 1 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize10mm
FlavorImprint Code4H2
Contains    
Packaging
#Item CodePackage Description
1NDC:54458-859-155 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07833605/27/2016
Labeler - International Laboratories, LLC (023569924)
Establishment
NameAddressID/FEIOperations
L. Perrigo Company006013346MANUFACTURE(54458-859), RELABEL(54458-859), REPACK(54458-859)

 
International Laboratories, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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