Cetirizine Hydrochloride

SPL v2

SPL

SPL Set ID 601c2846-30e7-40f1-96b4-64fbed719c0b

Route

ORAL

Published

Effective Date 2024-02-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (1 mg)

Inactive Ingredients

Acetic Acid Glycerin Methylparaben Propylene Glycol Propylparaben Water Sodium Acetate Anhydrous Sucralose

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

ANDA Active Since 2024-02-02

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

Section 50568-5

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

Section 50569-3

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

Section 50570-1

Do not useif 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

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 833-358-6431Monday to Friday 9:00am to 7:00pm EST

Other Information

do not use if carton is opened or if imprinted safety seal is broken or missing
see bottom panel for lot number and expiration date
store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucralose

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

Active Ingredient (in Each 5 Ml)

Cetirizine HCl 5 mg

Principal Display Panel 120 Ml Bottle Carton

NDC 70677-1236-1

COMPARE TO THE

ACTIVE INGREDIENT

IN CHILDREN'S ZYRTEC ^®*

Foster & Thrive™

Children's

All Day

Allergy

Cetirizine Hydrochloride

Oral Solution

1 mg/1 mL

ANTIHISTAMINE Allergy

Indoor & Outdoor Allergies

24 hour relief of:

Runny Nose
Itchy, Watery Eyes
Sneezing
Itchy Throat or Nose

Sugar Free

Ages 2 years & older

Dye Free

GRAPE FLAVOR

DOSING CUP ENCLOSED

4 FL OZ (120 mL)

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 ifan 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 aretaking tranquilizers or sedatives.

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not useif 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

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 833-358-6431Monday to Friday 9:00am to 7:00pm EST

Other Information (Other information)

do not use if carton is opened or if imprinted safety seal is broken or missing
see bottom panel for lot number and expiration date
store between 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucralose

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

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

Cetirizine HCl 5 mg

Principal Display Panel 120 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton)

NDC 70677-1236-1

COMPARE TO THE

ACTIVE INGREDIENT

IN CHILDREN'S ZYRTEC ^®*

Foster & Thrive™

Children's

All Day

Allergy

Cetirizine Hydrochloride

Oral Solution

1 mg/1 mL

ANTIHISTAMINE Allergy

Indoor & Outdoor Allergies

24 hour relief of:

Runny Nose
Itchy, Watery Eyes
Sneezing
Itchy Throat or Nose

Sugar Free

Ages 2 years & older

Dye Free

GRAPE FLAVOR

DOSING CUP ENCLOSED

4 FL OZ (120 mL)

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.", "53414-9": "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use.", "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", "Questions?": "call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST", "Other information": "do not use if carton is opened or if imprinted safety seal is broken or missing see bottom panel for lot number and expiration date store between 20° to 25°C (68° to 77°F)", "Inactive ingredients": "artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucralose", "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", "Active ingredient (in each 5 mL)": "Cetirizine HCl 5 mg", "PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton": "NDC 70677-1236-1 COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S ZYRTEC ® * Foster & Thrive™ Children's All Day Allergy Cetirizine Hydrochloride Oral Solution 1 mg/1 mL ANTIHISTAMINE Allergy Indoor & Outdoor Allergies 24 hour relief of: Runny Nose Itchy, Watery Eyes Sneezing Itchy Throat or Nose Sugar Free Ages 2 years & older Dye Free GRAPE FLAVOR DOSING CUP ENCLOSED 4 FL OZ (120 mL)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:29.855737 · Updated: 2026-03-14T23:09:18.179019