healthy accents cetirizine hydrochloride

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: DZA Brands LLC
NDC Code: 55316-458

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 CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-458
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
POLYDEXTROSE 
POVIDONES 
TITANIUM DIOXIDE 
TRIACETIN 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
POLYETHYLENE GLYCOLS 
STARCH, CORN 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize10mm
FlavorImprint Code4H2
Contains    
Packaging
#Item CodePackage Description
1NDC:55316-458-391 BOTTLE in 1 CARTON
130 TABLET in 1 BOTTLE
2NDC:55316-458-661 BLISTER PACK in 1 CARTON
214 TABLET in 1 BLISTER PACK
3NDC:55316-458-721 BOTTLE in 1 CARTON
360 TABLET in 1 BOTTLE
4NDC:55316-458-761 BOTTLE in 1 CARTON
4120 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07833601/15/2008
Labeler - DZA Brands LLC (090322194)

Revised: 08/2013
 
DZA Brands LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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