CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
DIRECT RX

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CETIRIZINE HYDROCHLORIDE

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.

Active Ingredients (in each tablet) Purpose
Cetirizine HCl 10 mg..............................................................................................Antihistimine

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

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.

drowsines may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinary.

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

if breast-feeding: not recommended
if pregnant: ask a health professional before use.

In case of overdose, get medical help or contact Poison Control Center right away.

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 sever 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

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CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-429(NDC:16571-402)
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
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
Product Characteristics
ColorwhiteScoreno score
ShapeBULLETSize8mm
FlavorImprint Code CTN;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-429-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/22/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782912/22/2016
Labeler - DIRECT RX (079254320)
Registrant - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320repack(61919-429)

Revised: 1/2023
Document Id: f213f0a8-4096-18e3-e053-2995a90a19f2
Set id: 4445548f-d11c-3c1b-e054-00144ff8d46c
Version: 3
Effective Time: 20230112
 
DIRECT RX