DailyMed - CETIRIZINE HYDROCHLORIDE 10 MG tablet, film coated

NDC Code(s): 10267-3579-1, 10267-3579-3, 10267-3579-4, 10267-3579-6, view more
10267-3579-7
Packager: Contract Pharmacal Corp.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 28, 2025

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Drug Facts
Active ingredient (in each tablet) Cetirizine Hydrochloride 10 mg

Active ingredient (in each tablet)

Cetirizine Hydrochloride 10 mg
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PURPOSE
Purpose - Antihistamine

Purpose

Antihistamine
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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

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
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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 ...

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.

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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 ...

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

store between 20° to 25°C (68° to 77°F).
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INACTIVE INGREDIENT
hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone, pregelatinized starch, and titanium dioxide.

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone, pregelatinized starch, and titanium dioxide.
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QUESTIONS
1-800-231-4670

1-800-231-4670
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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 ...

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®.
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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 - ...

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

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INGREDIENTS AND APPEARANCE

Product Information

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076047	04/16/2025

Labeler - Contract Pharmacal Corp. (057795122)

Registrant - Contract Pharmacal Corp. (057795122)

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

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

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

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

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	RxCUI	RxNorm NAME	RxTTY
1	1014678	cetirizine HCl 10 MG Oral Tablet	PSN
2	1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD
3	1014678	cetirizine HCl 10 MG Oral Tablet	SY

Label: CETIRIZINE HYDROCHLORIDE 10 MG tablet, film coated

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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

	NDC
1	10267-3579-1
2	10267-3579-3
3	10267-3579-4
4	10267-3579-6
5	10267-3579-7

Label: CETIRIZINE HYDROCHLORIDE 10 MG tablet, film coated

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

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Safety

Related Resources

More Info on this Drug

CETIRIZINE HYDROCHLORIDE 10 MG tablet, film coated

Number of versions: 1

CETIRIZINE HYDROCHLORIDE 10 MG tablet, film coated

CETIRIZINE HYDROCHLORIDE 10 MG tablet, film coated

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CETIRIZINE HYDROCHLORIDE 10 MG tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.