HEALTHY ACCENTS CETIRIZINE-D- cetirizine hcl, pseudoephedrine hcl tablet, extended release 
DZA Brands LLC

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DZA Brands, LLC Cetirizine-D Drug Facts

Active ingredient (in each extended release tablet)

Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg

Purpose

Antihistamine

Nasal Decongestant

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
•
nasal congestion
•
reduces swelling of nasal passages
•
temporarily relieves sinus congestion and pressure
•
temporarily restores freer breathing through the nose

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.
•
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

•
heart disease
•
thyroid disease
•
diabetes
•
glaucoma
•
high blood pressure
•
trouble urinating due to an enlarged prostate gland
•
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

•
do not use more than directed
•
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.
•
you get nervous, dizzy, or sleepless
•
symptoms do not improve within 7 days or are accompanied by fever

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.

Directions

•
do not break or chew tablet; swallow tablet whole

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

•
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, yellow iron oxide

Questions or comments?

1-866-322-2439

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Compare to Zyrtec-D® active ingredients

allergy & congestion

cetirizine-D

cetirizine hydrochloride & pseudoephedrine hydrochloride extended release tablets, 5mg/120mg

antihistamine/nasal decongestant

indoor & outdoor allergies

12 hour relief of:

sneezing

runny nose

sinus pressure

itchy, watery eyes

itchy throat or nose

nasal congestion

actual size

Cetirizine-D Carton Image 1

Cetirizine-D Carton Image 1

Cetirizine-D Carton Image 2

Cetirizine-D Carton Image 1

Cetirizine-D Carton Image 2

HEALTHY ACCENTS CETIRIZINE-D 
cetirizine hcl, pseudoephedrine hcl tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-176
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)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorWHITE (one side white one side light yellow) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code 5029;5;120
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-176-624 in 1 CARTON07/13/201111/01/2019
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07717007/13/201111/01/2019
Labeler - DZA Brands LLC (090322194)

Revised: 12/2018
 
DZA Brands LLC