CHILDRENS ALLERGY RELIEF- cetirizine hcl tablet, chewable

Childrens Allergy Relief by

Drug Labeling and Warnings

Childrens Allergy Relief by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF 
cetirizine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-578
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BETADEX (UNII: JV039JZZ3A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	PINK (peach color)	Score	no score
Shape	ROUND	Size	10mm
Flavor	TUTTI FRUTTI	Imprint Code	SZ;106
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50844-578-02	2 in 1 CARTON	10/31/2008
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078692	10/31/2008

Labeler - L.N.K. International, Inc. (038154464)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(50844-578)