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Childrens Allergy Relief by L.N.K. International, Inc.

Medically reviewed on April 26, 2018

Dosage form: tablet, chewable
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-578

Quality Plus 44-578

Active ingredient (in each chewable 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
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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 (1-800-222-1222) right away. 

Directions
  • may be taken with or without water
 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 severe
 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
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store between 20º-25ºC (68º-77ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

acesulfame potassium, artificial flavors, benzyl alcohol, betadex, colloidal silicon dioxide, di-alpha-tocopherol, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, talc, tutti frutti flavor

Questions or comments?

Call 1-800-426-9391 8:30 AM -4:00 PM ET, Monday-Friday 

Principal Display Panel

QUALITY
PLUS
 

NDC 50844-578-02

*Compare to the active ingredient
in Children's Zyrtec® Allergy

AGES 6+

CHILDREN'S
ALLERGY RELIEF

Cetirizine HCl Chewable 10 mg
Antihistamine
Indoor and Outdoor Allergies

Tutti Frutti
Flavored

12 Chewable Tablets

Actual Size

*This product is not manufactured or distributed by McNeil Consumer
Healthcare, owner of the registered trademark Children's Zyrtec® Allergy.
50844          ORG031357802                   Product of India

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

Quality Plus 44-578

CHILDRENS ALLERGY RELIEF 
cetirizine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-578
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
BENZYL ALCOHOL 
BETADEX 
SILICON DIOXIDE 
TOCOPHERYL NICOTINATE, D-.ALPHA. 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
TALC 
Product Characteristics
ColorPINK (peach color) Scoreno score
ShapeROUNDSize10mm
FlavorTUTTI FRUTTIImprint CodeSZ;106
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-578-022 BLISTER PACK in 1 CARTON
16 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07869210/31/2008
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(50844-578)

 
L.N.K. International, Inc.

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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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