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SPL v6

SPL

SPL Set ID 4de4f544-79cd-4a89-aafb-f2e2688b3c81

Route

ORAL

Published

Effective Date 2026-03-09

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 Sucrose

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

ANDA Active Since 2015-06-24

Description

Cetirizine hydrochloride USP 5 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Cetirizine hydrochloride USP 5 mg

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

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

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.

Questions?

call 1-855-274-4122

(Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Other Information

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

Inactive Ingredients

cherry mint flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate trihydrate, sucrose

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.

Stop Use and Ask A Doctor If

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

If Pregnant Or Breast Feeding:

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

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)

Active Ingredient (in Each 5 Ml)

Cetirizine hydrochloride USP 5 mg

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

Package Label Principal Display Panel 1 Mg/ml (120 Ml Bottle)

AUROHEALTH

NDC 58602-028-24

Cetirizine Hydrochloride

Oral Solution USP

1 mg/mL

antihistamine

ALLERGY

Indoor &

Outdoor

Allergies

L IQUID

4 fl oz (120 mL) Cherry Flavor

Package Label Principal Display Panel 1 Mg/ml Carton (120 Ml)

AUROHEALTH

NDC 58602-028-24

*Compare to active ingredient

in Children’s ZYRTEC^®

Cetirizine Hydrochloride

Oral Solution USP

1 mg/mL

antihistamine

ALLERGY

Indoor &

Outdoor

Allergies

LIQUID

24 Hour

relief of Sneezing Runny Nose

Itchy, Watery Itchy Throat Dye-Free

Eyes or Nose Alcohol-Free

Cherry Flavor

4 fl oz (120 mL)

Dosing cup

included

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

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

Do Not Use (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.

Questions?

call 1-855-274-4122

(Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

cherry mint flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate trihydrate, sucrose

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.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

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

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

Keep Out of Reach of Children. (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)

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

Cetirizine hydrochloride USP 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking tranquilizers or sedatives.

Package Label Principal Display Panel 1 Mg/ml (120 Ml Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL (120 mL Bottle))

AUROHEALTH

NDC 58602-028-24

Cetirizine Hydrochloride

Oral Solution USP

1 mg/mL

antihistamine

ALLERGY

Indoor &

Outdoor

Allergies

L IQUID

4 fl oz (120 mL) Cherry Flavor

Package Label Principal Display Panel 1 Mg/ml Carton (120 Ml) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL))

AUROHEALTH

NDC 58602-028-24

*Compare to active ingredient

in Children’s ZYRTEC^®

Cetirizine Hydrochloride

Oral Solution USP

1 mg/mL

antihistamine

ALLERGY

Indoor &

Outdoor

Allergies

LIQUID

24 Hour

relief of Sneezing Runny Nose

Itchy, Watery Itchy Throat Dye-Free

Eyes or Nose Alcohol-Free

Cherry Flavor

4 fl oz (120 mL)

Dosing cup

included

Advanced Ingredient Data

[{"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ACETIC ACID", "unii": "Q40Q9N063P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM ACETATE", "unii": "4550K0SC9B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "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", "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", "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.", "Questions?": "call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India", "Other information": "store between 20° to 25°C (68° to 77°F) do not use if carton is opened, or if cap safety seal is broken or missing. see bottom panel for lot number and expiration date", "Inactive ingredients": "cherry mint flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate trihydrate, sucrose", "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.", "Stop use and ask a doctor if": "an allergic reaction to this product occurs. Seek medical help right away.", "If pregnant or breast-feeding:": "if breast-feeding: not recommended if pregnant: ask a health professional before use.", "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)", "Active ingredient (in each 5 mL)": "Cetirizine hydrochloride USP 5 mg", "Ask a doctor before use if you have": "liver or kidney disease. Your doctor should determine if you need a different dose.", "Ask a doctor or pharmacist before use if you are": "taking tranquilizers or sedatives.", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL (120 mL Bottle)": "AUROHEALTH NDC 58602-028-24 Cetirizine Hydrochloride Oral Solution USP 1 mg/mL antihistamine ALLERGY Indoor & Outdoor Allergies L IQUID 4 fl oz (120 mL) Cherry Flavor", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)": "AUROHEALTH NDC 58602-028-24 *Compare to active ingredient in Children’s ZYRTEC ® Cetirizine Hydrochloride Oral Solution USP 1 mg/mL antihistamine ALLERGY Indoor & Outdoor Allergies LIQUID 24 Hour relief of Sneezing Runny Nose Itchy, Watery Itchy Throat Dye-Free Eyes or Nose Alcohol-Free Cherry Flavor 4 fl oz (120 mL) Dosing cup included"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:58.879903 · Updated: 2026-03-14T23:14:11.403934