CETIRIZINE HYDROCHLORIDE- cetirizine tablet 
Amneal Pharmaceuticals LLC

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CETIRIZINE HYDROCHLORIDE TABLETS

Drug Facts

ACTIVE INGREDIENT

(in each tablet)

Cetirizine HCl, USP 5 mg

PURPOSE

Antihistamine

INDICATIONS AND USAGE

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 DOCTOR

Ask a doctor before use if you have liver or kidney disease.  Your doctor should determine if you need a different dose.

ASK DOCTOR/PHARMACIST

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

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

PREGNANCY OR BREAST FEEDING

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 a Poison Control Center right away. (1-800-222-1222)

DIRECTIONS

Adults and children 6years and over1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours.
Adults 65years and over1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
Children under 6 years of ageask a doctor
Consumers with liver or kidney diseaseask a doctor

OTHER INFORMATION

Other information

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

INACTIVE INGREDIENTS

Inactive ingredients

lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.

OTC - QUESTIONS

Questions or Comments?

Call 1-877-835-5472

Monday through Friday 9AM - 5PM EST.

Distributed by: 
Amneal Pharmaceuticals LLC
Bridgewater, NJ08807

Rev. 08-2023-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

Carton
CETIRIZINE HYDROCHLORIDE 
cetirizine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-045
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize6mm
FlavorImprint Code IP;45
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65162-045-031 in 1 CARTON01/21/2010
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:65162-045-50500 in 1 BOTTLE; Type 0: Not a Combination Product01/21/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07878001/21/2010
Labeler - Amneal Pharmaceuticals LLC (123797875)
Establishment
NameAddressID/FEIBusiness Operations
Amneal Pharmaceuticals of New York, LLC831227801analysis(65162-045) , label(65162-045) , manufacture(65162-045) , pack(65162-045)

Revised: 8/2023
Document Id: 785feb22-255b-47c0-91eb-2915f55cac9e
Set id: 214936a2-adc4-422a-a8fe-4c3ce9e01f36
Version: 7
Effective Time: 20230808
 
Amneal Pharmaceuticals LLC