CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride tablet 
Proficient Rx LP

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Drug Facts

Active ingredient (in each tablet)

For 10 mg:

Cetirizine hydrochloride USP 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


For 5 mg:

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

For 10 mg:

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° to 25°C (68° to 77°F)
TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions?

call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

Code: TS/DRUGS/19/19

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10's Tablet Container Carton Label)

NDC 71205-700-10
*Compare to the active
ingredient of Zyrtec®

Allergy Relief
Cetirizine Hydrochloride Tablets USP 10 mg
Antihistamine
Original Prescription Strength

Indoor & Outdoor Allergies
24 Hour Relief of :

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

10 Tablets
10 mg each

71205-700-10

CETIRIZINE HYDROCHLORIDE (ALLERGY) 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-700(NDC:58602-445)
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (White to Off-white) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code X;36
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-700-066 in 1 BOTTLE; Type 0: Not a Combination Product01/29/2024
2NDC:71205-700-1010 in 1 BOTTLE; Type 0: Not a Combination Product10/20/2022
3NDC:71205-700-1212 in 1 BOTTLE; Type 0: Not a Combination Product01/29/2024
4NDC:71205-700-1414 in 1 BOTTLE; Type 0: Not a Combination Product01/29/2024
5NDC:71205-700-1515 in 1 BOTTLE; Type 0: Not a Combination Product01/29/2024
6NDC:71205-700-2020 in 1 BOTTLE; Type 0: Not a Combination Product01/29/2024
7NDC:71205-700-2121 in 1 BOTTLE; Type 0: Not a Combination Product01/29/2024
8NDC:71205-700-3030 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2022
9NDC:71205-700-6060 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2022
10NDC:71205-700-9090 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2022
11NDC:71205-700-00100 in 1 BOTTLE; Type 0: Not a Combination Product03/08/2024
12NDC:71205-700-72120 in 1 BOTTLE; Type 0: Not a Combination Product03/08/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09076008/05/2015
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(71205-700) , RELABEL(71205-700)

Revised: 3/2024
Document Id: c5844e33-c337-4b62-91ca-de3d388b7d45
Set id: d69083c4-b028-453c-8235-560b40ad358b
Version: 4
Effective Time: 20240301
 
Proficient Rx LP