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Cetirizine hydrochloride by Major Pharmaceuticals

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-6100

Cetirizine Hydrochloride Tablets

Active ingredient

Active ingredient: Cetirizine Hcl 10 mg.......Antihistamine

Purpose

Purpose: Antihistamine

Use

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.

Warning

Warnings: Do not use if you have ever had an allergic reaction to this product or any of it's ingredients or to an antihistamine containing hydroxyzine.

For external use only

Do not use

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

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

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

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

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Pregnancy/breast-feeding warning

If pregnant or breast-feeding: If breast feeding, not recommended. If pregnant- ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact poison control center right away. (1-800-222-1222).

Directions

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

Consumer with liver or kidney disease:    Ask a doctor

Other information

Store at controlled room temperature 15 and 30 degrees C (59-86 degrees F).

Inactive ingredients

Inactive Ingredients: Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide.

Questions?

To report adverse drug event call: (800) 616-2471

PRINCIPAL DISPLAY PANEL

Cetirizine Hcl 10 mg Tabs

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6100
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
HYPROMELLOSE 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 
POVIDONE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeRB80;
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-6100-61100 TABLET (100 TABLET) in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749806/25/2010
Labeler - Major Pharmaceuticals (191427277)

 
Major Pharmaceuticals

← See all Cetirizine hydrochloride brands

Medically reviewed on Sep 3, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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