Cetirizine Hydrochloride Tablets (allergy)

SPL v11

SPL

SPL Set ID 3cf969e6-6bc9-4dae-ab6a-b24c0fc46b25

Route

ORAL

Published

Effective Date 2024-09-13

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (5 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;2;0 Shape: round Shape: rectangle Color: white Size: 6 mm Size: 8 mm Size: 9 mm Score: 2

Marketing Status

ANDA Active Since 2015-08-05

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 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours.
adults 65 years and over	1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) 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

279 Princeton-Hightstown,

East Windsor, NJ 08520

Made in India

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.

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

Package Label Principal Display Panel 5 Mg (10 X 10 Blister Carton Label)

AUROHEALTH

NDC 58602-444-21

^*Compare to the active

ingredient of Zyrtec^®

Allergy Relief

Cetirizine Hydrochloride Tablets USP 5 mg

Antihistamine

Original Prescription Strength

Indoor & Outdoor Allergies

5 mg Strength Tablets

Take 1 to 2 tablets^* once daily depending

on the severity of your symptoms

^*Adults 65 and older take only one tablet per day

24 Hour relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

100 (10 x 10)

unit-dose Tablets

5 mg each

Package Label Principal Display Panel 10 Mg (10 X 10 Blister Carton Label)

AUROHEALTH

NDC 58602-445-21

^*Compare to the active

ingredient of Zyrtec^®

Allergy Relief

Cetirizine Hydrochloride Tablets USP 10 mg

Antihistamine

Original Prescription Strength

Indoor & Outdoor Allergies

10 mg Strength Tablets

24 Hour relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

100 (10x10) Tablets

10 mg each

Package Label Principal Display Panel 5 Mg (30's Tablet Container Carton Label)

AUROHEALTH

NDC 58602-444-09

^*Compare to the active

ingredient of Zyrtec^®

Original Prescription Strength

Allergy Relief

Cetirizine Hydrochloride

Tablets USP 5 mg

Antihistamine

Indoor & Outdoor Allergies

5 mg Strength Tablets

Take 1 to 2 tablets^* once daily

depending on the severity of

your symptoms

^*Adults 65 and older take only

one tablet per day

24 Hour relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

30 Tablets

5 mg each

Package Label Principal Display Panel 10 Mg (30's Tablet Container Carton Label)

AUROHEALTH

NDC 58602-445-09

^*Compare to the active

ingredient of Zyrtec^®

Allergy Relief

Cetirizine Hydrochloride Tablets USP 10 mg

Antihistamine

Original Prescription Strength

Indoor & Outdoor Allergies

10 mg Strength Tablets

24 Hour relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

30 Tablets

10 mg each

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 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours.
adults 65 years and over	1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) 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

279 Princeton-Hightstown,

East Windsor, NJ 08520

Made in India

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.

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 5 Mg (10 X 10 Blister Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg (10 x 10 Blister Carton Label))

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

100 (10 x 10)

unit-dose Tablets

5 mg each

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

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

100 (10x10) Tablets

10 mg each

Package Label Principal Display Panel 5 Mg (30's Tablet Container Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label))

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

30 Tablets

5 mg each

Package Label Principal Display Panel 10 Mg (30's Tablet Container Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label))

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

30 Tablets

10 mg each

Advanced Ingredient Data

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"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": ""}, {"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", 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"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": ""}, {"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 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours. adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) 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 279 Princeton-Hightstown, East Windsor, NJ 08520 Made in India", "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.", "Ask a doctor or pharmacist before use if you are": "taking tranquilizers or sedatives.", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg (10 x 10 Blister Carton Label)": "AUROHEALTH NDC 58602-444-21 * Compare to the active ingredient of Zyrtec ® Allergy Relief Cetirizine Hydrochloride Tablets USP 5 mg Antihistamine Original Prescription Strength Indoor & Outdoor Allergies 5 mg Strength Tablets Take 1 to 2 tablets * once daily depending on the severity of your symptoms * Adults 65 and older take only one tablet per day 24 Hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 100 (10 x 10) unit-dose Tablets 5 mg each", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)": "AUROHEALTH NDC 58602-445-21 * Compare to the active ingredient of Zyrtec ® Allergy Relief Cetirizine Hydrochloride Tablets USP 10 mg Antihistamine Original Prescription Strength Indoor & Outdoor Allergies 10 mg Strength Tablets 24 Hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 100 (10x10) Tablets 10 mg each", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)": "AUROHEALTH NDC 58602-444-09 * Compare to the active ingredient of Zyrtec ® Original Prescription Strength Allergy Relief Cetirizine Hydrochloride Tablets USP 5 mg Antihistamine Indoor & Outdoor Allergies 5 mg Strength Tablets Take 1 to 2 tablets * once daily depending on the severity of your symptoms * Adults 65 and older take only one tablet per day 24 Hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 30 Tablets 5 mg each", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)": "AUROHEALTH NDC 58602-445-09 * Compare to the active ingredient of Zyrtec ® Allergy Relief Cetirizine Hydrochloride Tablets USP 10 mg Antihistamine Original Prescription Strength Indoor & Outdoor Allergies 10 mg Strength Tablets 24 Hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 30 Tablets 10 mg each"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:34.612628 · Updated: 2026-03-14T23:03:44.598062