DZA Brands, LLC Cetirizine Hydrochloride Tablets, 10mg Drug Facts

healthy accents cetirizine hydrochloride by

Drug Labeling and Warnings

healthy accents cetirizine hydrochloride by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTHY ACCENTS CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
DZA Brands LLC

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DZA Brands, LLC Cetirizine Hydrochloride Tablets, 10mg Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl 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

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

  • do not use if blister unit is broken or torn (Blister Only)
  • do not use if printed foil under cap is broken or missing (Bottle Only)
  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

Questions or comments?

1-866-322-2439

Principal Display Panel

all day allergy

cetirizine hydrochloride tablets, 10mg

antihistamine

original prescription strength

indoor & outdoor allergies

24 hour relief of:

sneezing

runny nose

itchy, watery eyes

itchy throat or nose

Compare to Zyrtec® active ingredient

actual size

120 tablets

Healthy Accents All day Allergy Image
HEALTHY ACCENTS CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55316-458
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
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize10mm
FlavorImprint Code 4H2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55316-458-391 in 1 CARTON06/29/200912/01/2019
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 55316-458-661 in 1 CARTON01/15/200809/15/2017
214 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 55316-458-721 in 1 CARTON10/03/200905/22/2018
360 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 55316-458-761 in 1 CARTON05/30/201307/09/2018
4120 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07833601/15/200812/01/2019
Labeler - DZA Brands LLC (090322194)

Revised: 11/2019
Document Id: 3902e3e1-af83-421f-8374-386cf766a651
Set id: b3d8ff4b-c4a1-4800-8015-59e09ef0f492
Version: 4
Effective Time: 20191115
 
DZA Brands LLC