CETIRIZINE HYDROCHLORIDE 10 MG- cetirizine hydrochloride 10 mg tablet, film coated 
Contract Pharmacal Corp.

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3579

Drug Facts

Active ingredient (in each tablet)

Cetirizine Hydrochloride 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 sedatives or tranquilizers.

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 (1-800-222-1222) right away.

Directions

Adults and children 6 years and overone 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 overask a doctor
Children under 6 years of ageask a doctor
Consumers with liver or kidney diseaseask a doctor

Other information

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

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone, pregelatinized starch, and titanium dioxide.

1-800-231-4670

DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by:
Contract Pharmacal Corp.
165 Oser Avenue
Hauppauge, NY 11788 USA
www.cpc.com

* This product is not manufactured or distributed by Kenvue Brands LLC., the owner of the registered trademark Zyrtec®.

NDC 10267-3579-6
*Compares to Zyrtec®Allergy Original Prescription Strength

Allergy

Cetirizine HCl Tablets, USP

10mg/ Antihistamine

Indoor & Outdoor Allergies

24 Hour

RELIEF OF
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

365 Tablets

10 mg each

CPC label

CETIRIZINE HYDROCHLORIDE 10 MG 
cetirizine hydrochloride 10 mg tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-3579
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (Biconvex) Size8mm
FlavorImprint Code C;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10267-3579-31 in 1 CARTON12/31/2025
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:10267-3579-71 in 1 CARTON12/31/2025
260 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:10267-3579-11 in 1 CARTON12/31/2025
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:10267-3579-6365 in 1 BOTTLE; Type 0: Not a Combination Product04/16/2025
5NDC:10267-3579-4100 in 1 BOTTLE; Type 0: Not a Combination Product05/31/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07604704/16/2025
Labeler - Contract Pharmacal Corp. (057795122)
Registrant - Contract Pharmacal Corp. (057795122)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp.057795122pack(10267-3579) , label(10267-3579)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp.968335112manufacture(10267-3579)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp.968334974manufacture(10267-3579)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp.079157508manufacture(10267-3579)

Revised: 5/2025
Document Id: 3633ac85-4814-e6a7-e063-6294a90a375d
Set id: 84459f11-3405-4a8e-be38-333b7de2a578
Version: 2
Effective Time: 20250528
 
Contract Pharmacal Corp.