Cetirizine Hydrochloride Hives Relief CETIRIZINE AMNEAL PHARMACEUTICALS LLC FDA Approved INDICATIONS AND USAGE Relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
FunFoxMeds box
Route
ORAL
Applications
ANDA078780

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT (in each tablet) Cetirizine HCl USP 5 mg
Inactive Ingredients
INACTIVE INGREDIENTS Inactive Ingredients lactose monohydrate magnesium stearate polyvinyl alcohol polyethylene glycol povidone starch talc and titanium dioxide.
Strengths
5 mg
Treats Conditions
Indications And Usage Relieves Itching Due To Hives Urticaria This Product Will Not Prevent Hives Or An Allergic Skin Reaction From Occurring
Pill Appearance
Shape: oval Color: white Imprint: IP;45

Identifiers & Packaging

Container Type BOX
UNII
64O047KTOA
Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Label Carton

Package Descriptions
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Label Carton

Overview

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

Indications & Usage

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

Dosage & Administration

DIRECTIONS Adults and children 6years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours. Adults 65years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. Children under 6 years of age ask a doctor Consumers with liver or kidney disease ask a doctor

Warnings & Precautions
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.
Purpose

PURPOSE Antihistamine

Do Not Use

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 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 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 its ingredients or to an antihistamine containing hydroxyzine.

When Using

WHEN USING 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 & Ask a Doctor

STOP USE 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

Keep Out of Reach of Children

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)

Questions

OTC - QUESTIONS Questions or Comments? Call 1-877-835-5472 Monday through Friday 9AM - 5PM EST.


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