CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Bryant Ranch Prepack

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Cetirizine Hydrochloride Tablets USP
5 mg, Allergy

ACTIVE INGREDIENTS (IN EACH TABLET)

Cetirizine HCl USP 5 mg

PURPOSE

Antihistimine

USES

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

WARNINGS:

DO NOT USE

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 DOCTOR

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

WHEN USING THIS PRODUCT

  • 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

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 Poison Control Center right away. (1-800-222-1222)

DIRECTIONS


Adults and children 6years and over

1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours

Adults 65 years and over

1 tablet once a day; do not take more than 1 tablet in 24 hours

Children under 6 years of age

Ask a doctor

Consumers with liver or kidney disease

Ask a doctor



OTHER INFORMATION

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

INACTIVE INGREDIENTS

hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

QUESTIONS

Call 1-844-874-7464

Manufactured by:

Unique Pharmaceutical Labs,

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India.

Distributed by:

Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

M.L. G/1430     July 2020

129575


HOW SUPPLIED

NDC: 63629-4914-1: 30 Tablets in a BOTTLE

Cetirizine HCL 5mg Tablet

Label
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63629-4914(NDC:16571-401)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (White) Scoreno score
ShapeBULLET (Barrel Shaped) Size7mm
FlavorImprint Code CTN;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-4914-130 in 1 BOTTLE; Type 0: Not a Combination Product02/19/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782910/01/2009
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-4914) , RELABEL(63629-4914)

Revised: 2/2022
Document Id: e51f8f6e-a301-438f-9de7-b24a91d9fccc
Set id: ddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be7
Version: 1002
Effective Time: 20220221
 
Bryant Ranch Prepack