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SPL v1

SPL

SPL Set ID 0b6e8c63-a76c-4184-a9cc-9691378c3ee5

Route

ORAL

Published

Effective Date 2021-03-26

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 2021-03-12

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
do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.

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)

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/16/2014

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 Capsule)

Cetirizine HCl USP 10 mg

Package Label Principal Display Panel 10 Mg (40's Capsule Container Label)

PrimaryHealth NDC 58602-863-12

ALLERGY

Original

Prescription Strength

Cetirizine HCl Capsules

10 mg

Antihistamine

INDOOR + OUTDOOR ALLERGIES

40 LIQUID GELS*

* LIQUID-FILLED CAPSULES

Package Label Principal Display Panel 10 Mg (40's Capsule Container Carton Label)

NDC 58602-863-12

PrimaryHealth

COMPARE TO Zyrtec^®

active ingredient^*

Original Prescription Strength

ALLERGY

Cetirizine HCl Capsules

10 mg

Antihistamine

INDOOR +OUTDOOR ALLERGIES

24 HOUR

RELIEF OF

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

CZ10

(Actual size)

40 LIQUID GELS*

* 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
do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.

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)

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/16/2014

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 Capsule) (Active ingredient (in each capsule))

Cetirizine HCl USP 10 mg

Package Label Principal Display Panel 10 Mg (40's Capsule Container Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (40's Capsule Container Label))

PrimaryHealth NDC 58602-863-12

ALLERGY

Original

Prescription Strength

Cetirizine HCl Capsules

10 mg

Antihistamine

INDOOR + OUTDOOR ALLERGIES

40 LIQUID GELS*

* LIQUID-FILLED CAPSULES

Package Label Principal Display Panel 10 Mg (40's Capsule Container Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (40's Capsule Container Carton Label))

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

CZ10

(Actual size)

40 LIQUID GELS*

* 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 do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.", "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) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/16/2014", "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 capsule)": "Cetirizine HCl USP 10 mg", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (40's Capsule Container Label)": "PrimaryHealth NDC 58602-863-12 ALLERGY Original Prescription Strength Cetirizine HCl Capsules 10 mg Antihistamine INDOOR + OUTDOOR ALLERGIES 40 LIQUID GELS* * LIQUID-FILLED CAPSULES", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (40's Capsule Container Carton Label)": "NDC 58602-863-12 PrimaryHealth COMPARE TO Zyrtec ® active ingredient * Original Prescription Strength ALLERGY Cetirizine HCl Capsules 10 mg Antihistamine INDOOR +OUTDOOR ALLERGIES 24 HOUR RELIEF OF Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose CZ10 (Actual size) 40 LIQUID GELS* * LIQUID-FILLED CAPSULES"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:28.188640 · Updated: 2026-03-14T22:59:28.137987