CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Bryant Ranch Prepack

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Cetirizine Hydrochloride Tablets USP
5 mg, Allergy

Active Ingredient (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 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

  • 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 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 6 years 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     Jul. 2020

129575

HOW SUPPLIED

Cetirizine Hydrochloride Tablets 5 mg

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

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

Cetirizine Hydrochloride Tablets 5 mg

Label
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC 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: 5/2024
Document Id: 3db925ae-d07d-4da4-9dab-155db44d75a0
Set id: ddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be7
Version: 1003
Effective Time: 20240521
 
Bryant Ranch Prepack