FDA Label for Cetirizine Hydrochloride (hives Relief)
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH CAPSULE)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING:
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- 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)
Cetirizine Hydrochloride (hives Relief) Product Label
The following document was submitted to the FDA by the labeler of this product Aurohealth Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
- if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
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.
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 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
* Please review the disclaimer below.