SPL v4
SPL
SPL Set ID f0f486e1-2eeb-4eaa-b557-908bcbf973a8
Route
ORAL
Published
Effective Date 2020-09-14
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 (Hives Relief) Drug Facts

Purpose

Antihistamine


Medication Information

Purpose


Antihistamine

Description

Cetirizine HCl Capsules 10 mg (Hives Relief) Drug Facts

Uses


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

Section 42229-5

Cetirizine HCl Capsules 10 mg (Hives Relief)



Drug Facts

Section 50568-5

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

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


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





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 occuring. 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.
Other Information
  •  store between 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

2572 Brunswick Pike

Lawrenceville, NJ 08648



Made in India



Code: TS/DRUGS/22/2009

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 Capsule)

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


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

HIVES Relief     NDC 58602-808-04

Original Prescription Strength



Cetirizine HCl Capsules

10 mg                                             CZ10

Antihistamine                            (Actual Size) 



READ AND KEEP THE OUTER PACKAGE FOR

COMPLETE WARNINGS AND INFORMATION



12 LIQUID GELS*


* LIQUID-FILLED CAPSULES

AUROHEALTH

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

NDC 58602-808-04

*Compare to the active ingredient in Zyrtec®

Original Prescription Strength

HIVES Relief



Cetirizine HCl Capsules


10 mg

Antihistamine



24 hour                                                      CZ10


Relief of itching due to hives               (Actual Size)



12 LIQUID GELS*


* LIQUID-FILLED CAPSULES

AUROHEALTH




Structured Label Content

Uses


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

Section 42229-5 (42229-5)

Cetirizine HCl Capsules 10 mg (Hives Relief)



Drug Facts

Section 50568-5 (50568-5)

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

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


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





Do Not Use (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 occuring. 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.
Other Information (Other information)
  •  store between 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

2572 Brunswick Pike

Lawrenceville, NJ 08648



Made in India



Code: TS/DRUGS/22/2009

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 Capsule) (Active ingredient (in each capsule))

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


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

HIVES Relief     NDC 58602-808-04

Original Prescription Strength



Cetirizine HCl Capsules

10 mg                                             CZ10

Antihistamine                            (Actual Size) 



READ AND KEEP THE OUTER PACKAGE FOR

COMPLETE WARNINGS AND INFORMATION



12 LIQUID GELS*


* LIQUID-FILLED CAPSULES

AUROHEALTH

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 58602-808-04

*Compare to the active ingredient in Zyrtec®

Original Prescription Strength

HIVES Relief



Cetirizine HCl Capsules


10 mg

Antihistamine



24 hour                                                      CZ10


Relief of itching due to hives               (Actual Size)



12 LIQUID GELS*


* LIQUID-FILLED CAPSULES

AUROHEALTH




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)