CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE - cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release 
Aurohealth LLC

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Drug Facts

Active ingredients (in each extended release tablet)

Cetirizine HCl USP 5 mg
Pseudoephedrine HCl  USP 120 mg

Purpose

Antihistamine
Nasal decongestant

Uses

Warnings

Do not use

Ask a doctor before use if you have

 

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

When using this product

Stop use and ask a doctor if


If pregnant or breast-feeding:

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

adults and children 12 years and over
take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. 
adults 65 years and over
ask a doctor
children under 12 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose.

Questions or comments?
call 1-855-274-4122
(Monday - Friday 8:30 AM to 5:00 PM EST)

Distributed by: AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: AP/DRUGS/04/2016


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg/120 mg (12 x 2) Blister Carton

AUROHEALTH
NDC 58602-703-09
*Compare to the active
ingredients of Zyrtec-D®
Original Prescription Strength
Cetirizine Hydrochloride and
Pseudoephedrine Hydrochloride
Extended-Release Tablets, USP
5 mg/ 120 mg
Antihistamine/Nasal Decongestant
Allergy & Sinus
INDOOR & OUTDOOR
ALLERGIES

12 HOUR RELIEF

NASAL CONGESTION & SINUS  PRESSURE

(Actual Size) 

24 EXTENDED-RELEASE TABLETS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg/120 mg (12 x 2) Blister Carton

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-703
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorYELLOW (Pale Yellow to Yellow) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code K15
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-703-764 in 1 CARTON03/08/2023
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:58602-703-752 in 1 CARTON03/08/2023
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:58602-703-5312 in 1 CARTON03/08/2023
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:58602-703-0912 in 1 CARTON03/08/2023
42 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21240903/08/2023
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(58602-703) , MANUFACTURE(58602-703)

Revised: 3/2023
Document Id: 4f6fe4bd-b825-44a1-8264-74c664f76746
Set id: 26f2c3c1-a2f2-474a-950a-8cfe07f289fa
Version: 2
Effective Time: 20230320
 
Aurohealth LLC