children's zyrtec ®

SPL v10

SPL

SPL Set ID ee8695ac-1293-4e43-ac7c-a64e21a0ca0a

Route

oral

Published

Effective Date 2018-10-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

cetirizine (5 mg)

Inactive Ingredients

sorbitol solution anhydrous citric acid propylene glycol water sodium benzoate sucralose

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

nda active Since 2009-01-20

Purpose

Antihistamine

Description

Drug Facts

Medication Information

Warnings

Warnings

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

Purpose

Antihistamine

Directions

use only with enclosed dosing cup
find right dose on chart below
mL = milliliter

adults and children 6 years and over	5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over	5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age	2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other Information

store between 20° to 25°C (68° to 77°F)
do not use if carton is opened. Do not use if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing
see bottom panel for lot number and expiration date

Inactive Ingredients

anhydrous citric acid, flavors, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Description

Drug Facts

Principal Display Panel

NDC 50580-721-05

Children's

ZYRTEC ^®

ALLERGY

Cetirizine HCl oral solution

1 mg / ml/ antihistamine

Indoor & Outdoor Allergies

2 yrs & older

24 Hour

Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Dye-Free

Sugar-Free

Alcohol-Free

Bubble Gum Flavor

4 fl oz (118 ml)

Dosing Cup Included

Questions?

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

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.

Section 53414-9

If pregnant or breast-feeding:

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

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
in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.

Active Ingredient (in Each 5 Ml)

Cetirizine HCl 5 mg

Structured Label Content

Warnings

Warnings

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

Purpose

Antihistamine

Directions

use only with enclosed dosing cup
find right dose on chart below
mL = milliliter

adults and children 6 years and over	5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over	5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age	2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other Information (Other information)

store between 20° to 25°C (68° to 77°F)
do not use if carton is opened. Do not use if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing
see bottom panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, flavors, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-721-05

Children's

ZYRTEC ^®

ALLERGY

Cetirizine HCl oral solution

1 mg / ml/ antihistamine

Indoor & Outdoor Allergies

2 yrs & older

24 Hour

Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Dye-Free

Sugar-Free

Alcohol-Free

Bubble Gum Flavor

4 fl oz (118 ml)

Dosing Cup Included

Questions?

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

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding:

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

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
in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Cetirizine HCl 5 mg

Advanced Ingredient Data

[{"name": "SORBITOL SOLUTION", "unii": "8KW3E207O2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

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.", "53414-9": "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use.", "Purpose": "Antihistamine", "Warnings": "Warnings", "Directions": "use only with enclosed dosing cup find right dose on chart below mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours. children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. children under 2 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 carton is opened. Do not use if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing see bottom panel for lot number and expiration date", "Inactive ingredients": "anhydrous citric acid, flavors, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose", "PRINCIPAL DISPLAY PANEL": "NDC 50580-721-05 Children's ZYRTEC ® ALLERGY Cetirizine HCl oral solution 1 mg / ml/ antihistamine Indoor & Outdoor Allergies 2 yrs & older 24 Hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Dye-Free Sugar-Free Alcohol-Free Bubble Gum Flavor 4 fl oz (118 ml) Dosing Cup Included", "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 in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.", "Active ingredient (in each 5 mL)": "Cetirizine HCl 5 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:07.551730 · Updated: 2026-03-14T23:12:34.529887