Package/label Principal Display Panel

Package/label Principal Display Panel
SPL v2
SPL
SPL Set ID c0e58e3d-bdb1-4752-b0ff-5301bc32db91
Route
ORAL
Published
Effective Date 2020-12-03
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 50565-1

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

Section 50566-9

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

Section 50567-7

• drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • 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 hydroxytoluene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

Section 51945-4

Compare to the active ingredient of Zyrtec ® Liquid Gels ORIGINAL PRESCRIPTION STRENGTH ALLERGY RELIEF CETIRIZINE HYDROCHLORIDE CAPSULES, 10 mg ANTIHISTAMINE INDOOR & OUTDOOR ALLERGIES 24 HOUR RELIEF OF Sneezing – Runny nose Itchy, watery eyes Itchy throat or nose 24 Hour ACTUAL SIZE 40 LIQUID GELS** **LIQUID FILLED CAPSULES

Section 53413-1

1-800-719-9260

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

Section 60561-8

• avoid high humidity and excessive heat above 40°C (104°F) • protect from light


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 50565-1 (50565-1)

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

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 • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • 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 hydroxytoluene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

Section 51945-4 (51945-4)

Compare to the active ingredient of Zyrtec ® Liquid Gels ORIGINAL PRESCRIPTION STRENGTH ALLERGY RELIEF CETIRIZINE HYDROCHLORIDE CAPSULES, 10 mg ANTIHISTAMINE INDOOR & OUTDOOR ALLERGIES 24 HOUR RELIEF OF Sneezing – Runny nose Itchy, watery eyes Itchy throat or nose 24 Hour ACTUAL SIZE 40 LIQUID GELS** **LIQUID FILLED CAPSULES

Section 53413-1 (53413-1)

1-800-719-9260

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

Section 60561-8 (60561-8)

• avoid high humidity and excessive heat above 40°C (104°F) • protect from light


Raw Label Data

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