Cetirizine Hydrochloride (hives Relief) Capsule
FDA Label NDC 58602-808

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Cetirizine Hydrochloride (hives Relief) (NDC 58602-808). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each capsule), purpose, uses, warnings, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Cetirizine HCl Capsules 10 mg (Hives Relief)

Drug Facts

Active Ingredient (In Each Capsule)

Cetirizine HCI USP 10 mg

Purpose


Antihistamine

Uses


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

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.


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.

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

Otc - Ask Doctor/Pharmacist

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

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]

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 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)

Manufactured for:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648


Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahabubnagar (Dt)-509302
India

M.L.No.: 22/MN/AP/2009/F/R

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 Label))

Package Label-principal Display Panel (10 mg (12's Capsule Container Label))

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

NDC 58602-808-04
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


Package Label-principal Display Panel (10 mg (Carton Label))

Package Label-principal Display Panel (10 mg (Carton Label))

* Please review the disclaimer below.