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SPL v4

SPL

SPL Set ID ffbca2a4-8df0-4c85-adf9-9414cd706fb2

Route

ORAL

Published

Effective Date 2026-02-26

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Ferrosoferric Oxide Gelatin, Unspecified Glycerin Hypromellose 2910 (6 Mpa.s) Polyethylene Glycol 400 Propylene Glycol Water Sodium Hydroxide Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: CZ10 Shape: oval Color: yellow Size: 13 mm Score: 1

Marketing Status

ANDA Active Since 2018-07-20

Description

Cetirizine HCl Capsules 10 mg (Allergy) Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Cetirizine HCl Capsules 10 mg (Allergy) 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

Cetirizine HCl Capsules 10 mg (Allergy)

Drug Facts

Section 50568-5

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

Section 50569-3

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

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

adults and children 6 years and over	one 10 mg capsule once daily; do not take more than one 10 mg capsule 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

Other Information

store at 20°-25°C (68°-77°F)
avoid high humidity and excessive heat above 40°C (104°F)
protect from light

Inactive Ingredients

black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution

Questions Or Comments?

call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)

^*This product is not manufactured or distributed by the owners of Zyrtec^®.

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

When Using This Product

drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
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 Capsule)

Cetirizine HCl USP 10 mg

Package Label Principal Display Panel 10 Mg (12's Capsule Container Label)

NDC 58602-806-04

Cetirizine HCl Capsules

10 mg

Antihistamine

Indoor & Outdoor

Allergies

CZ10

(Actual size)

KEEP CARTON FOR COMPLETE WARNINGS

AND PRODUCT INFORMATION

AUROHEALTH

12 SOFTGELS**

(** Liquid-filled capsules)

Package Label Principal Display Panel 10 Mg (12's Capsule Container Carton Label)

NDC 58602-806-04

^*Compare to the active ingredient in Zyrtec^®

Cetirizine HCl Capsules

10 mg

Antihistamine

Indoor & Outdoor CZ10

Allergies (Actual size)

24 HOUR

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

AUROHEALTH

12 SOFTGELS**

(** Liquid-filled capsules)

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)

Cetirizine HCl Capsules 10 mg (Allergy)

Drug Facts

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

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

adults and children 6 years and over	one 10 mg capsule once daily; do not take more than one 10 mg capsule 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

Other Information (Other information)

store at 20°-25°C (68°-77°F)
avoid high humidity and excessive heat above 40°C (104°F)
protect from light

Inactive Ingredients (Inactive ingredients)

black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution

Questions Or Comments? (Questions or comments?)

call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)

^*This product is not manufactured or distributed by the owners of Zyrtec^®.

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

When Using This Product (When using this product)

drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
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 Capsule) (Active ingredient (in each capsule))

Cetirizine HCl USP 10 mg

Package Label Principal Display Panel 10 Mg (12's Capsule Container Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label))

NDC 58602-806-04

Cetirizine HCl Capsules

10 mg

Antihistamine

Indoor & Outdoor

Allergies

CZ10

(Actual size)

KEEP CARTON FOR COMPLETE WARNINGS

AND PRODUCT INFORMATION

AUROHEALTH

12 SOFTGELS**

(** Liquid-filled capsules)

Package Label Principal Display Panel 10 Mg (12's Capsule Container Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12's Capsule Container Carton Label))

NDC 58602-806-04

^*Compare to the active ingredient in Zyrtec^®

Cetirizine HCl Capsules

10 mg

Antihistamine

Indoor & Outdoor CZ10

Allergies (Actual size)

24 HOUR

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

AUROHEALTH

12 SOFTGELS**

(** Liquid-filled capsules)

Advanced Ingredient Data

[{"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (6 MPA.S)", "unii": "0WZ8WG20P6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "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": "Cetirizine HCl Capsules 10 mg (Allergy) Drug Facts", "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.", "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": "adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule 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", "Other information": "store at 20°-25°C (68°-77°F) avoid high humidity and excessive heat above 40°C (104°F) protect from light", "Inactive ingredients": "black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution", "Questions or comments?": "call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) * This product is not manufactured or distributed by the owners of Zyrtec ® . Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India", "When using this product": "drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks 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 capsule)": "Cetirizine HCl USP 10 mg", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label)": "NDC 58602-806-04 Cetirizine HCl Capsules 10 mg Antihistamine Indoor & Outdoor Allergies CZ10 (Actual size) KEEP CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION AUROHEALTH 12 SOFTGELS** (** Liquid-filled capsules) ", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12's Capsule Container Carton Label)": "NDC 58602-806-04 * Compare to the active ingredient in Zyrtec ® Cetirizine HCl Capsules 10 mg Antihistamine Indoor & Outdoor CZ10 Allergies (Actual size) 24 HOUR Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose AUROHEALTH 12 SOFTGELS** (** Liquid-filled capsules) "}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:44.008335 · Updated: 2026-03-14T23:14:02.652954