CETIRIZINE- cetirizine tablet 
Contract Pharmacy Services-PA

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

Cetirizine 10mg 680
"These highlights do not include all the information needed to use" "see full prescribing information for" "Initial U.S. Approval"

DOSAGE AND ADMINISTRATION

adults and children 6 years and over (4)

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. (4)

adults 65 years and over (4)

ask a doctor (4)

children under 6 years of age (4)

ask a doctor (4)

consumers with liver or kidney disease (4)

ask a doctor (4)

INDICATIONS AND USAGE

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: (6)


runny nose

sneezing

itchy, watery eyes

itching of the nose or throat (6)

Revised: 2/2018

FULL PRESCRIBING INFORMATION: CONTENTS*

*
Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION

Cetirizine HCL 10MG

Antihistamine

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)

corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

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)

cet

CETIRIZINE 
cetirizine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-680(NDC:45802-919)
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)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize10mm
FlavorImprint Code 4H2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67046-680-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product02/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07833602/14/2018
Labeler - Contract Pharmacy Services-PA (945429777)
Establishment
NameAddressID/FEIBusiness Operations
Coupler Enterprises Inc.945429777repack(67046-680)

Revised: 4/2018
Document Id: 6a707324-b32c-9741-e053-2a91aa0a2af2
Set id: 6a707324-b32b-9741-e053-2a91aa0a2af2
Version: 1
Effective Time: 20180422
 
Contract Pharmacy Services-PA