Prevent an allergic reaction from happening at school.

Formucare Cetirizine

Pronunciation

Generic Name: cetirizine hydrochloride
Dosage Form: tablet

Access Business Group International LLC Cetirizine Hydrochloride Tablets 10 mg Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

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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.

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 printed foil under cap is broken or missing
  • store between 20° to 25°C (68° to 77°F)

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

Formucare Cetirizine HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10056-458
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 4H2
Contains         
Packaging
# Item Code Package Description
1 NDC:10056-458-39 1 BOTTLE (BOTTLE) in 1 CARTON
1 30 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078336 07/01/2009
Labeler - Access Business Group International LLC (609682641)
Revised: 05/2009
 
Access Business Group International LLC



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