Zyrtec Allergy

SPL v17

SPL

SPL Set ID 6a962a1c-c197-492b-bfa6-e0c28eda1533

Route

ORAL

Published

Effective Date 2019-12-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Anhydrous Citric Acid Silicon Dioxide Crospovidone Hydroxypropyl Cellulose, Unspecified Magnesium Stearate Mannitol Microcrystalline Cellulose Sodium Bicarbonate Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate Copolymer Sodium Starch Glycolate Type A Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: Z10 Shape: round Color: white Size: 10 mm Score: 1

Marketing Status

NDA Completed Since 2014-01-20 Until 2017-03-31

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 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.

Directions

Tablet melts in mouth. Can be taken with or without water.

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

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). Avoid high humidity.
do not use if blister unit is torn or broken

Inactive Ingredients

amino methacrylate copolymer, anhydrous citric acid, colloidal silicon dioxide, crospovidone, flavors, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, sodium bicarbonate, sodium starch glycolate, sucralose

Principal Display Panel

New look

Same

relief

Original Prescription Strength

NDC 50580-778-24

ZYRTEC ^®

ALLERGY

Cetirizine HCl

orally disintegrating tablets

10 mg/antihistamine

Indoor &

Outdoor

Allergies

10 mg

Dye-Free

DISSOLVE TABS

24

Hour

Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Actual Size

Citrus Flavor

Melts in your mouth

ORALLY

DISINTEGRATING

TABLETS

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

If Pregnant Or Breast Feeding

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

Active Ingredient (in Each Tablet)

Cetirizine HCl 10 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 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.

Purpose

Antihistamine

Directions

Tablet melts in mouth. Can be taken with or without water.

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

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). Avoid high humidity.
do not use if blister unit is torn or broken

Inactive Ingredients (Inactive ingredients)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

New look

Same

relief

Original Prescription Strength

NDC 50580-778-24

ZYRTEC ^®

ALLERGY

Cetirizine HCl

orally disintegrating tablets

10 mg/antihistamine

Indoor &

Outdoor

Allergies

10 mg

Dye-Free

DISSOLVE TABS

24

Hour

Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Actual Size

Citrus Flavor

Melts in your mouth

ORALLY

DISINTEGRATING

TABLETS

When Using This Product (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

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

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

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

Cetirizine HCl 10 mg

Advanced Ingredient Data

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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.", "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.", "Purpose": "Antihistamine", "Directions": "Tablet melts in mouth. Can be taken with or without water. 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", "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). Avoid high humidity. do not use if blister unit is torn or broken", "Inactive ingredients": "amino methacrylate copolymer, anhydrous citric acid, colloidal silicon dioxide, crospovidone, flavors, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, sodium bicarbonate, sodium starch glycolate, sucralose", "PRINCIPAL DISPLAY PANEL": "New look Same relief Original Prescription Strength NDC 50580-778-24 ZYRTEC ® ALLERGY Cetirizine HCl orally disintegrating tablets 10 mg/antihistamine Indoor & Outdoor Allergies 10 mg Dye-Free DISSOLVE TABS 24 Hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Actual Size Citrus Flavor Melts in your mouth 24 ORALLY DISINTEGRATING TABLETS", "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", "If pregnant or breast-feeding": "if breast-feeding: not recommended if pregnant: ask a health professional before use.", "Active ingredient (in each tablet)": "Cetirizine HCl 10 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:53.844352 · Updated: 2026-03-14T23:08:19.346855