Zyrtec Allergy

SPL v3

SPL

SPL Set ID 2c1ecee3-c2c1-25a2-e063-6294a90aad54

Route

ORAL

Published

Effective Date 2025-01-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (5 mg)

Inactive Ingredients

Polyethylene Glycol, Unspecified Titanium Dioxide Lactose Monohydrate Silicon Dioxide Croscarmellose Sodium Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

Imprint: Z;5MG Shape: rectangle Color: white Size: 8 mm Score: 1

Marketing Status

NDA Active Since 2025-02-15

Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

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

Section 50568-5

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 50569-3

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

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.

Section 53414-9

If pregnant or breast-feeding:

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

Directions

adults and children 6 years and over	1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours.
adults 65 years and over	1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Questions?

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

Other Information

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

■ do not use if pouch is torn or damaged

■ meets USP Dissolution Test 2

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Principal Display Panel

NDC 50580-754-15

ZYRTEC®

ALLERGY

Cetirizine HCl Tablets

5mg/antihistamine

Indoor &

Outdoor

Allergies

5mg Strength Tablets

24 Hour relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

15 Tablets

5 mg each

Take 1 to 2 tablets* once daily depending on the severity of your symptoms

*Adults 65 and older take only one tablet per day

Actual Size

15 Tablets

Active Ingredient (in Each Tablet)

Cetirizine HCl 5 mg

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding:

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

Purpose

Antihistamine

Directions

adults and children 6 years and over	1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours.
adults 65 years and over	1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Questions?

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

Other Information (Other information)

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

■ do not use if pouch is torn or damaged

■ meets USP Dissolution Test 2

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-754-15

ZYRTEC®

ALLERGY

Cetirizine HCl Tablets

5mg/antihistamine

Indoor &

Outdoor

Allergies

5mg Strength Tablets

24 Hour relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

15 Tablets

5 mg each

Take 1 to 2 tablets* once daily depending on the severity of your symptoms

*Adults 65 and older take only one tablet per day

Actual Size

15 Tablets

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Cetirizine HCl 5 mg

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50567-7": "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", "50568-5": "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "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.", "53414-9": "If pregnant or breast-feeding: ■ if breast-feeding: not recommended ■ if pregnant: ask a health professional before use.", "Purpose": "Antihistamine", "Directions": "adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours. adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "Questions?": "call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)", "Other information": "■ store between 20° to 25°C (68° to 77°F) ■ do not use if pouch is torn or damaged ■ meets USP Dissolution Test 2", "Inactive ingredients": "colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide", "PRINCIPAL DISPLAY PANEL": "NDC 50580-754-15 ZYRTEC® ALLERGY Cetirizine HCl Tablets 5mg /antihistamine Indoor & Outdoor Allergies 5mg Strength Tablets 24 Hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 15 Tablets 5 mg each Take 1 to 2 tablets* once daily depending on the severity of your symptoms *Adults 65 and older take only one tablet per day Actual Size 15 Tablets", "Active ingredient (in each tablet)": "Cetirizine HCl 5 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:34.903301 · Updated: 2026-03-14T23:09:26.831955