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SPL v1

SPL

SPL Set ID bd489217-bf7c-429b-a58c-426104f7e779

Route

ORAL

Published

Effective Date 2025-12-16

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 2010-02-02

Description

Cetirizine hydrochloride USP 5 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Cetirizine hydrochloride USP 5 mg

Uses

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

Severe Allergy Warning:

Get emergency help immediately if you have hives along with any of the following symptoms:

trouble swallowing
dizziness or loss of consciousness
swelling of tongue
swelling in or around mouth
trouble speaking
drooling
wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

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 under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Do Not Use

to prevent hives from any known cause such as:
- foods
- insect stings
- medicines
- latex or rubber gloves

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

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.

Inactive Ingredients

banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, 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

Stop Use and Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.
symptoms do not improve after 3 days of treatment
the hives have lasted more than 6 weeks

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.
hives that are an unusual color, look bruised or blistered
hives that do not itch

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 58602-036-15

Children's

Cetirizine Hydrochloride

Oral Solution USP 1 mg/mL

antihistamine

HIVES RELIEF

24

Hour r elief Reduces Itching Reduces

Due to Hives Hives

6 yrs &

older

4 fl oz (120 mL)

Grape Flavor

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

AUROHEALTH

NDC 58602-036-15

*Compare to the active ingredient

in Children's ZYRTEC^®

Children's

Cetirizine Hydrochloride

Oral Solution USP

1 mg/mL

antihistamine

Hives

Relief

6 yrs &

older

HIVES RELIEF

24 Hour relief

Reduces Itching Reduces

Due to Hives Hives

Grape Flavor

4 fl oz (120 mL)

Dosing cup

included

Structured Label Content

Uses

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Purpose

Antihistamine

Warnings

Severe Allergy Warning:

Get emergency help immediately if you have hives along with any of the following symptoms:

trouble swallowing
dizziness or loss of consciousness
swelling of tongue
swelling in or around mouth
trouble speaking
drooling
wheezing or problems breathing

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 under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Do Not Use (Do not use)

to prevent hives from any known cause such as:
- foods
- insect stings
- medicines
- latex or rubber gloves

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.

Inactive Ingredients (Inactive ingredients)

banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, 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

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.
symptoms do not improve after 3 days of treatment
the hives have lasted more than 6 weeks

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.
hives that are an unusual color, look bruised or blistered
hives that do not itch

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))

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

24 Hour relief

Reduces Itching Reduces

Due to Hives Hives

Grape 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": "reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.", "Purpose": "Antihistamine", "Warnings": "Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately . Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine . If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.", "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 under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "Do not use": "to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. 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.", "Inactive ingredients": "banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, 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", "Stop use and ask a doctor if": "an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks", "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. hives that are an unusual color, look bruised or blistered hives that do not itch", "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 58602-036-15 Children's Cetirizine Hydrochloride Oral Solution USP 1 mg/mL antihistamine HIVES RELIEF 24 Hour r elief Reduces Itching Reduces Due to Hives Hives 6 yrs & older 4 fl oz (120 mL) Grape Flavor", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)": "AUROHEALTH NDC 58602-036-15 *Compare to the active ingredient in Children's ZYRTEC ® Children's Cetirizine Hydrochloride Oral Solution USP 1 mg/mL antihistamine Hives Relief 6 yrs & older HIVES RELIEF 24 Hour relief Reduces Itching Reduces Due to Hives Hives Grape Flavor 4 fl oz (120 mL) Dosing cup included"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:58.894699 · Updated: 2026-03-14T23:12:02.945870