CETIRIZINE- cetiirizine tablet

Cetirizine by

Drug Labeling and Warnings

Cetirizine by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Ceitirizine HCL 10mg

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

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 ■ ask a doctor
kidney disease

Other information

■ store between 20° and 25°C (68° and 77°F)
■ contains no ingredient made from a gluten-containing grain (Wheat, barley or rye)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline
cellulose, polyethylene glycol, titanium dioxide

Questions?

Call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

PDP

INGREDIENTS AND APPEARANCE

CETIRIZINE 
cetiirizine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-764
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white (white to off white)	Score	2 pieces
Shape	RECTANGLE (rounded off rectangular)	Size	9mm
Flavor		Imprint Code	G;4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-764-65	365 in 1 BOTTLE; Type 0: Not a Combination Product	10/16/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209274	10/16/2023

Labeler - CVS PHARMACY, INC (062312574)