CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Proficient Rx LP

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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:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

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 1-866-562-4597

Manufactured by:

Unique Pharmaceutical Labs,

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

Mumbai 400 030, India.

Distributed by:

Rising Pharmaceuticals, Inc.

Saddle Brook, NJ 07663

M. L. G/1430      May 2018

120004

Repackaged By;

Proficient Rx LP

Thousand Oaks 91320

Cetirizine Hydrochloride Tablets USP 5 mg

NDC 71205-093-30

Original Prescription Strength

Cetirizine Hydrochloride
Tablets 5 mg

30 Tablets

71205-093-30
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-093(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:71205-093-1515 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
2NDC:71205-093-3030 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
3NDC:71205-093-6060 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
4NDC:71205-093-9090 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07782910/01/2009
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(71205-093) , RELABEL(71205-093)

Revised: 10/2019
Document Id: 26beeb96-f0b4-4e99-ba9d-3b27c67659dc
Set id: 9c2b97d9-9990-46ab-9027-c34ffb07ce8f
Version: 3
Effective Time: 20191001
 
Proficient Rx LP