Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, chewable 
Major Pharmaceuticals

----------

Drug Facts

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 reactions 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.

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

• Store between 20 to 25 C (68 to 77 F)
• See end flap for expiration date and lot number

Inactive ingredients

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

Questions? (800) 616-2471

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Zyrtec (R) Allergy.

50844

ORG060857802

Distributed by MAJOR (R) PHARMACEUTICALS

31778 Enterprise Drive, Livonia, MI 48150 USA    M-126

Rev 08/12

Re-order No. 255535

Product of India     

OTC - ACTIVE INGREDIENT SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

All Day Children's Allergy - Cetirizine HCl 10mg Chewable

NDC: 0904-5879-12

Children's

Cetirizine HCl Chewable Tablets

10 mg

antihistamine

Tutti Frutti Flavored

30 Tablets

Do not use if individual blister unit is open or torn

ALLERGY

Indoor & Outdoor Allergies

24 hour Relief of

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

6 yrs. and older 10 mg each

Principal Display Panel

NDC: 0904-5879-12

Children's

Cetirizine HCl Chewable Tablets

10 mg

antihistamine

Tutti Frutti Flavored

30 Tablets

Do not use if individual blister unit is open or torn

ALLERGY

Indoor & Outdoor Allergies

24 hour Relief of

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

6 yrs. and older 10 mg each

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5879(NDC: 0781-5284)
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)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	YELLOW (peach, mottled)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	SZ;106
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5879-12	12 in 1 CARTON; Type 0: Not a Combination Product	02/14/2008	08/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078692	02/14/2008	08/17/2019

Labeler - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
Major Pharmaceuticals		191427277	REPACK(0904-5879)

Revised: 8/2018

Document Id: 2dfc1eee-f18b-476c-98b1-75c88e194b03

34390-5

Set id: 048c42a3-80b3-451a-8526-42e2bdfd2170

Version: 3

Effective Time: 20180808