CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Bryant Ranch Prepack

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Cetirizine Hydrochloride Tablets USP, 10 mg, Allergy

ACTIVE INGREDIENTS

Active Ingredients (in each tablet)                                                Purpose

Cetirizine HCl USP 10 mg................................................................Antihistimine

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 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 tothis 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.

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 overAsk a doctor
Children under 6 years of ageAsk a doctor
Consumers with liver or kidney diseaseAsk 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

126406


HOW SUPPLIED

NDC: 63629-8041-1: 60 Tablets in a BOTTLE

CETRIZINE HCL 10MG TABLET

Label
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-8041(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
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) Size8mm
FlavorImprint Code CTN;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-8041-160 in 1 BOTTLE; Type 0: Not a Combination Product07/15/201909/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782910/01/200909/08/2022
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-8041) , RELABEL(63629-8041)

Revised: 9/2022
Document Id: 853cc575-6b53-4fbe-95ce-33882a967cbd
Set id: 48d61a14-3276-45e0-ba98-0e08c0b49196
Version: 3
Effective Time: 20220908
 
Bryant Ranch Prepack