CETIRIZINE HYDROCHLORIDE HIVES RELIEF- 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

Relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

WARNINGS

Severe Allergy Warning: Get emergency help immediately if you have hives along

with any of the following symptoms:

• trouble swallowing

• dizziness or loss of consciousness

• swelling of tongue

• swelling in or around mouth

• trouble speaking

• drooling

• wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine . If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

DO NOT USE

Do not use

• to prevent hives from any known cause such as:

• foods • insect stings • medicines • latex or rubber gloves

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for medical exam. Your doctor may be able to help you find a cause.

• if you have ever had an allergic reaction to this product or 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.

• hives that are an unusual color, look bruised or blistered

• hives that do not itch

ASK DOCTOR/PHARMACIST

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

WHEN USING

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.

• symptoms do not improve after 3 days of treatment

• the hives have lasted more than 6 weeks

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, NJ 08807

Rev. 08-2023-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

Carton
CETIRIZINE HYDROCHLORIDE  HIVES RELIEF
cetirizine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-145
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:65162-145-031 in 1 CARTON01/21/2010
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:65162-145-50500 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(65162-145) , label(65162-145) , manufacture(65162-145) , pack(65162-145)

Revised: 8/2023
Document Id: 577bbdcd-1819-408b-9d08-40da69977583
Set id: aad39214-5bf1-427b-a00e-410224c51c95
Version: 6
Effective Time: 20230808
 
Amneal Pharmaceuticals LLC