CETIRIZINE HYDROCHLORIDE 10 MG tablet, film coated

Cetirizine Hydrochloride 10 mg by

Drug Labeling and Warnings

Cetirizine Hydrochloride 10 mg by is a Otc medication manufactured, distributed, or labeled by Contract Pharmacal Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Cetirizine Hydrochloride 10 mg

PURPOSE

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

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 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 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).

INACTIVE INGREDIENT

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

QUESTIONS

1-800-231-4670

SPL UNCLASSIFIED SECTION

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®.

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 10 MG 
cetirizine hydrochloride 10 mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10267-3579
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)
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
Color	white	Score	no score
Shape	ROUND (Biconvex)	Size	8mm
Flavor		Imprint Code	C;2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10267-3579-3	1 in 1 CARTON	12/31/2025
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 10267-3579-7	1 in 1 CARTON	12/31/2025
2		60 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 10267-3579-1	1 in 1 CARTON	12/31/2025
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 10267-3579-6	365 in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2025
5	NDC: 10267-3579-4	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076047	04/16/2025

Labeler - Contract Pharmacal Corp. (057795122)

Registrant - Contract Pharmacal Corp. (057795122)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corp.		057795122	pack(10267-3579) , label(10267-3579)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corp.		968335112	manufacture(10267-3579)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corp.		968334974	manufacture(10267-3579)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corp.		079157508	manufacture(10267-3579)