CETIRIZINE- cetirizine hydrochloride tablet 
Bryant Ranch Prepack

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Perrigo Cetirizine Hydrochloride Tablets 10 mg Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl 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

•
store between 20 - 25°C (68 - 77°F)
•
do not use if printed foil under cap is broken or missing

Inactive ingredients

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

Questions or comments?

1-800-719-9260

HOW SUPPLIED

Product: 63629-3708

NDC: 63629-3708-3 7 TABLET in a BOTTLE

NDC: 63629-3708-4 10 TABLET in a BOTTLE

NDC: 63629-3708-6 90 TABLET in a BOTTLE

NDC: 63629-3708-2 14 TABLET in a BOTTLE

NDC: 63629-3708-5 15 TABLET in a BOTTLE

NDC: 63629-3708-7 20 TABLET in a BOTTLE

NDC: 63629-3708-1 30 TABLET in a BOTTLE

NDC: 63629-3708-8 60 TABLET in a BOTTLE

NDC: 63629-3708-9 100 TABLET in a BOTTLE

Cetirizine 10mg Tablet

Label Image
CETIRIZINE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-3708(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)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize10mm
FlavorImprint Code 4H2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-3708-515 in 1 BOTTLE; Type 0: Not a Combination Product04/29/201011/27/2019
2NDC:63629-3708-690 in 1 BOTTLE; Type 0: Not a Combination Product04/29/201011/27/2019
3NDC:63629-3708-9100 in 1 BOTTLE; Type 0: Not a Combination Product04/03/200811/27/2019
4NDC:63629-3708-860 in 1 BOTTLE; Type 0: Not a Combination Product04/29/201011/27/2019
5NDC:63629-3708-37 in 1 BOTTLE; Type 0: Not a Combination Product04/29/201011/27/2019
6NDC:63629-3708-410 in 1 BOTTLE; Type 0: Not a Combination Product04/29/201011/27/2019
7NDC:63629-3708-720 in 1 BOTTLE; Type 0: Not a Combination Product04/29/201011/27/2019
8NDC:63629-3708-130 in 1 BOTTLE; Type 0: Not a Combination Product04/29/201011/27/2019
9NDC:63629-3708-214 in 1 BOTTLE; Type 0: Not a Combination Product04/29/201011/27/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07833612/27/200711/27/2019
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-3708) , RELABEL(63629-3708)

Revised: 8/2021
Document Id: 3213ef52-e849-4d0e-bed4-45654f4be103
Set id: 6e7cc082-fa81-40cc-a1a6-41fd4f6a8c04
Version: 5
Effective Time: 20210817
 
Bryant Ranch Prepack