Product Label

Product Label
SPL v4
SPL
SPL Set ID ae4b478a-452a-464d-9e6e-5bb987d98bd4
Route
ORAL
Published
Effective Date 2025-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Cetirizine HCl 10 mg


Medication Information

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

Dosage and Administration

Adults and children 6 years and over One 10 mg capsule once daily; do not take more than one 10 mg capsule 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

Description

Cetirizine HCl 10 mg

Section 42229-5

Compare to the active ingredient in ZYRTEC®* Indoor & Outdoor Allergies Original Prescription Strength Allergy Relief CETIRIZINE HYDROCHLORIDE CAPSULES, 10 mg Antihistamine 24 Hour Relief of: Sneezing Runny nose Itchy, watery eyes Itchy throat or nose SOFTGELS †Liquid-Filled Capsules *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 ©2018 CVS/pharmacy CVS.com® 1-800-SHOP CVS

Section 44425-7

store at 20ºto 25 o C (68 o to 77 o F) avoid high humidity and excessive heat above 40 o C (104 o F) protect from light

Section 50565-1

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery

Section 50568-5

 taking tranquilizers or sedatives.

Section 50569-3

liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Section 51727-6

Butylated hydroxytolene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, Sorbitan, Sorbitol

Section 51945-4

CVS HEALTH Allergy Relief

Section 53413-1

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Section 53414-9

if breast-feeding: not recommended if pregnant: ask a health professional before use.

Section 55105-1

Antihistamine

Section 55106-9

Cetirizine HCl 10 mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Adults and children 6 years and over One 10 mg capsule once daily; do not take more than one 10 mg capsule 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

Section 42229-5 (42229-5)

Compare to the active ingredient in ZYRTEC®* Indoor & Outdoor Allergies Original Prescription Strength Allergy Relief CETIRIZINE HYDROCHLORIDE CAPSULES, 10 mg Antihistamine 24 Hour Relief of: Sneezing Runny nose Itchy, watery eyes Itchy throat or nose SOFTGELS †Liquid-Filled Capsules *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 ©2018 CVS/pharmacy CVS.com® 1-800-SHOP CVS

Section 44425-7 (44425-7)

store at 20ºto 25 o C (68 o to 77 o F) avoid high humidity and excessive heat above 40 o C (104 o F) protect from light

Section 50565-1 (50565-1)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery

Section 50568-5 (50568-5)

 taking tranquilizers or sedatives.

Section 50569-3 (50569-3)

liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Section 51727-6 (51727-6)

Butylated hydroxytolene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, Sorbitan, Sorbitol

Section 51945-4 (51945-4)

CVS HEALTH Allergy Relief

Section 53413-1 (53413-1)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Section 53414-9 (53414-9)

if breast-feeding: not recommended if pregnant: ask a health professional before use.

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Cetirizine HCl 10 mg


Raw Label Data

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