Cetirizine Hydrochloride Tablets
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Granules Pharmaceuticals Inc. for the product Cetirizine Hydrochloride - Hives (NDC 70010-293). 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 cetirizine hydrochloride tablets, active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Cetirizine HCl 10 mg
Antihistamine
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
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.
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 occurring. 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.
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
taking tranquilizers or sedatives.
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
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
| 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 |
◾store between 20° to 25°C (68° to 77°F)
◾Contains no ingredient made from a gluten-containing grain (wheat, barley or rye).
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.
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