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SPL v3

SPL

SPL Set ID 73122009-531b-4929-bf57-494a6fc65b73

Route

ORAL

Published

Effective Date 2025-10-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Hypromellose 2910 (5 Mpa.s) Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 400 Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: X;36 Shape: round Color: white Size: 8 mm Score: 1

Marketing Status

ANDA Active Since 2022-04-01

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

Warnings

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

For 5 mg:

adults and children 6 years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over	1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

For 10 mg:

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 1-855-274-4122

Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/19/1993

Other Information

•
store between 20° to 25°C (68° to 77°F)
•
TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

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.

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 Tablet)

For 5 mg:

Cetirizine hydrochloride USP 5 mg

For 10 mg:

Cetirizine hydrochloride USP 10 mg

Ask A Doctor Before Use If You Have

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

Package Label Principal Display Panel 10 Mg

AUROHEALTH

Repackaged By: Preferred Pharmaceuticals Inc.

NDC 68788-8204

Original Prescription Strength

Cetirizine

Hydrochloride

Tablets USP

10 mg

Antihistamine

Allergy

Indoor & Outdoor Allergies

24 hour

Relief of

•
Sneezing
•
Runny Nose
•
Itchy, Watery Eyes
•
Itchy Throat or Nose

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

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

Purpose

Antihistamine

Warnings

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

For 5 mg:

adults and children 6 years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over	1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

For 10 mg:

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 1-855-274-4122

Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/19/1993

Other Information (Other information)

•
store between 20° to 25°C (68° to 77°F)
•
TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

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.

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 Tablet) (Active ingredient (in each tablet))

For 5 mg:

Cetirizine hydrochloride USP 5 mg

For 10 mg:

Cetirizine hydrochloride USP 10 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.

Package Label Principal Display Panel 10 Mg (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg)

AUROHEALTH

Repackaged By: Preferred Pharmaceuticals Inc.

NDC 68788-8204

Original Prescription Strength

Cetirizine

Hydrochloride

Tablets USP

10 mg

Antihistamine

Allergy

Indoor & Outdoor Allergies

24 hour

Relief of

•
Sneezing
•
Runny Nose
•
Itchy, Watery Eyes
•
Itchy Throat or Nose

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

taking tranquilizers or sedatives.

Advanced Ingredient Data

[{"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (5 MPA.S)", "unii": "R75537T0T4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "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", "42229-5": "Drug Facts", "Purpose": "Antihistamine", "Warnings": "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": "For 5 mg: adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor For 10 mg: 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 1-855-274-4122 Distributed by: AUROHEALTH LLC 2572 Brunswick Pike Lawrenceville, NJ 08648 Made in India Code: TS/DRUGS/19/1993", "Other information": "• store between 20° to 25°C (68° to 77°F) • TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.", "Inactive ingredients": "colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.", "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.", "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 tablet)": "For 5 mg: Cetirizine hydrochloride USP 5 mg For 10 mg: Cetirizine hydrochloride USP 10 mg", "Ask a doctor before use if you have": "liver or kidney disease. Your doctor should determine if you need a different dose.", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg": "AUROHEALTH Repackaged By: Preferred Pharmaceuticals Inc. NDC 68788-8204 Original Prescription Strength Cetirizine Hydrochloride Tablets USP 10 mg Antihistamine Allergy Indoor & Outdoor Allergies 24 hour Relief of • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose", "Ask a doctor or pharmacist before use if you are": "taking tranquilizers or sedatives."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:33.821825 · Updated: 2026-03-14T23:13:02.501548