CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Publix Super Markets Inc

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Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

Cetirizine HCl, USP 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 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 IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
store between 68° to 77° F (20° to 25° C)

INACTIVE INGREDIENTS

Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton

NDC 56062-939-60

INDOOR & OUTDOOR ALLERGIES
ORIGINAL PRESCRIPTION STRENGTH
24-HOUR

allergyrelief

CETIRIZINE HYDROCHLORIDE TABLETS USP, 10 mg

ANTIHISTAMINE

24-hour relief of:

Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose

ACTUAL SIZE

60
TABLETS
10 mg EACH

Compare to Active Ingredient in Zyrtec®

spl-publix-cetirizine-10mg-60ct-label
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-939
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
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeRECTANGLE (Rounded-Off) Size9mm
FlavorImprint Code R152
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56062-939-5414 in 1 BLISTER PACK; Type 0: Not a Combination Product12/27/2007
2NDC:56062-939-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2007
3NDC:56062-939-6060 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749812/27/2007
Labeler - Publix Super Markets Inc (006922009)
Registrant - Sun Pharmaceutical Industries Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(56062-939)

Revised: 8/2019
Document Id: acd5c107-c9fc-42fd-baf2-714888f59bd4
Set id: a0a063a1-e067-480e-afab-7f01165025f4
Version: 2
Effective Time: 20190819
 
Publix Super Markets Inc