FDA Label for Cetirizine Hydrochloride (hives Relief)

View Indications, Usage & Precautions

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

Drug Facts

Active Ingredient (In Each Tablet)

For 5 mg:

Cetirizine hydrochloride USP 5 mg

For 10 mg:

Cetirizine hydrochloride USP 10 mg

Purpose

Antihistamine

Uses

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

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

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

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

For 5 mg:

adults and children 6 years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
adults 65 years and over	1 tablet once a day; do not take more than 1 tablet in 24 hours.
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

For 10 mg:

adults and children 6 years and over	one 10 mg tablet once daily; do not take more than one 10 mg tablet 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° to 25°C (68° to 77°F)
TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions?

call 1-855-274-4122

Keep the carton. It contains important information.

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

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India

M.L.No.: 19/HD/AP/95/F/R

Package Label-Principal Display Panel - 5 Mg (30'S Tablet Container Carton Label)

AUROHEALTH
Original Prescription Strength                 NDC 58602-446-09
Cetirizine
Hydrochloride
Tablets USP 5 mg
Antihistamine HIVES Relief

24 hour
Relief of Itching
Due to Hives

30
Tablets
5 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label) - cetirizine fig1

Package Label-Principal Display Panel - 5 Mg (10 X 10 Blister Carton Label)

AUROHEALTH
NDC 58602-446-21
Original Prescription Strength
Cetirizine
Hydrochloride
Tablets USP
5 mg
Antihistamine
HIVES Relief

24 hour
Relief of Itching Due to Hives

100 (10 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (10 x 10 Blister Carton Label) - cetirizine fig2

Package Label-Principal Display Panel - 10 Mg (30'S Tablet Container Carton Label)

AUROHEALTH
Original Prescription Strength
NDC 58602-447-09
Cetirizine
Hydrochloride
Tablets USP 10 mg
Antihistamine
6 yrs & older
HIVES Relief
24 hour
Relief of itching
Due to Hives

30
Tablets
10 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label) - cetirizine hives fig3

Package Label-Principal Display Panel - 10 Mg (10 X 10 Blister Carton Label)

AUROHEALTH
NDC 58602-447-21
Original Prescription Strength
Cetirizine
Hydrochloride
Tablets USP
10 mg
Antihistamine
6 yrs & older
HIVES Relief

24 hour
Relief of Itching Due to Hives
100 (10 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label) - cetirizine hives fig4

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