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Cetirizine Hydrochloride by Mylan Pharmaceuticals Inc.

Dosage form: tablet, film coated
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg
Labeler: Mylan Pharmaceuticals Inc.
NDC Code: 0378-3635

Drug Facts

Active Ingredient (in each tablet)

Cetirizine hydrochloride USP, 5 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.

Directions

adults and children 6 years and over

1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.

adults 65 years and over

1 tablet once a day; do not take more than 1 tablet in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

Questions?

Call 1-877-446-3679 (1-877-4-INFO-RX)

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

PRINCIPAL DISPLAY PANEL - 5 mg Allergy

NDC 0378-3635-01

Cetirizine HCl
Tablets, USP
Allergy
5 mg
Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

RM-AR3635A5      100 Tablets

Tamper Evident: do not use if foil seal
under cap is missing, open or broken.

PRINCIPAL DISPLAY PANEL - 10 mg Allergy

NDC 0378-3637-01

Cetirizine HCl
Tablets, USP
Allergy
10 mg
Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

RM-AR3637A5      100 Tablets     

Tamper Evident: do not use if foil seal
under cap is missing, open or broken.

Active Ingredient (in each tablet)
Cetirizine hydrochloride USP, 10 mg

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

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0378-3635
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeM;C35
Contains    
Packaging
#Item CodePackage Description
1NDC:0378-3635-01100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07667712/27/2007
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0378-3637
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeM;C37
Contains    
Packaging
#Item CodePackage Description
1NDC:0378-3637-01100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2NDC:0378-3637-05500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07667712/27/2007
Labeler - Mylan Pharmaceuticals Inc. (059295980)

 
Mylan Pharmaceuticals Inc.

← See all Cetirizine Hydrochloride brands

Medically reviewed on Feb 9, 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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