CAREALL CETIRIZINE HCL- cetirizine tablet 
New World Imports

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Drug Facts

Cetirizine 10mg

Antihistamine

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose, sneezing, itchy, watery eys, itching of the nose or throat

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or 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 sedatives or tranquilizers

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.

Adult and children over 6 years old: One 10mg tablet once daily: no more than one 10mg tablet in 24 hours.  A 5mg 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

If pregnant of breast-feeding:

If breast-feeding: not recommended.

If pregnant: ask a health professional before use.

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Store between 20-25 degrees celcius (68-77 degrees farhenheit).

Do not use if imprinted seal under bottle cap is broken or missing

You may report side effects 1-888-952-0050

Cetirizine Label

CAREALL CETIRIZINE HCL 
cetirizine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-076
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
Colorwhite (White to off white) Score2 pieces
ShapeRECTANGLE (rounded off rectangular) Size9mm
FlavorImprint Code G;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-076-0130 in 1 BOTTLE; Type 0: Not a Combination Product03/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20927403/02/2020
Labeler - New World Imports (075372276)
Registrant - New World Imports (075372276)

Revised: 2/2020
Document Id: cd0a528a-91d4-4ae8-adeb-59f1728886ad
Set id: 0542dfb2-6ef3-4242-b8fc-9e889757cbd7
Version: 2
Effective Time: 20200219
 
New World Imports