FORMUCARE CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet 
Access Business Group International LLC

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Access Business Group International LLC Cetirizine Hydrochloride Tablets 10 mg 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:

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

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

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.

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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Principal Display Panel

Indoor & Outdoor Allergies

Cetirizine Hydrochloride Tablets 10 mg

Antihistamine

Allergy

Original Prescription Strength

24 Hour Relief of:

Runny Nose

Itchy, Watery Eyes

Sneezing

Itchy Throat or Nose

Actual Size

Cetirizine Hydrochloride Tablets 10 mg Carton

Cetirizine Hydrochloride Tablets 10 mg Carton


FORMUCARE CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride   tablet
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)10056-458
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorWHITEScore no score
ShapeOVALSize10mm
FlavorImprint Code 4H2
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
110056-458-391 BOTTLE In 1 CARTONcontains a BOTTLE
130 TABLET In 1 BOTTLEThis package is contained within the CARTON (10056-458-39)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07833607/01/2009

Labeler - Access Business Group International LLC (609682641)
Revised: 05/2009Access Business Group International LLC