CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Granules USA, Inc.

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CETIRIZINE HYDROCHLORIDE TABLETS, USP 10 mg
ANTIHISTAMINE
24 HOUR
INDOOR & OUTDOOR ALLERGIES

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:

■ 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 kidney disease
- ask a doctor

Other information

■ store between 20° to 25°C (68° to 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

90 count

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69848-006
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (White to off-white) Score2 pieces
ShapeRECTANGLE (round-off rectangular shaped tablets) Size9mm
FlavorImprint Code G;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69848-006-0990 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20927406/30/2021
Labeler - Granules USA, Inc. (137098864)

Revised: 12/2023
Document Id: 0c8ecc47-6442-6193-e063-6394a90afecc
Set id: c8d711cd-7214-c7d5-e053-2995a90a6b67
Version: 3
Effective Time: 20231215
 
Granules USA, Inc.