Cetirizine Hydrochloride CETIRIZINE AMNEAL PHARMACEUTICALS LLC FDA Approved Uses relieves itching due to hives (urticaria). This product will not prevent hives or a allergic skin reaction from occurring.
FunFoxMeds box
Route
ORAL
Applications
ANDA090765
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT (in each 5 mL teaspoonful) Cetirizine HCl 5 mg
Inactive Ingredients
INACTIVE INGREDIENTS Sucrose Glycerin Propylene Glycol Methylparaben Propylparaben Sodium Acetate Glacial Acetic Acid Artificial Grape Flavor Purified Water. Questions? Call 1-877-835-5472 Monday through Friday 9AM – 5PM EST. *This product is not manufactured or distributed by McNeil-PPC Inc. distributor of Zyrtec ® . Zyrtec ® is a registered trademark of UCB Pharma S.A. Distributed by: Amneal Pharmaceuticals Glasgow KY 42141 Rev. 03-2015-01
Strengths
5 ml 5 mg
Treats Conditions
Uses Relieves Itching Due To Hives Urticaria This Product Will Not Prevent Hives Or A Allergic Skin Reaction From Occurring
Pill Appearance
Color: yellow

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0365162003864
UNII
64O047KTOA
Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1 mg/mL Label 1 mg/mL Carton

Package Descriptions
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1 mg/mL Label 1 mg/mL Carton

Overview

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

Indications & Usage

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

Dosage & Administration

Directions use only with enclosed dosing cup find right dose on chart below mL = milliliter adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 56 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. 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 NECKBAND IMPRINTED “SEALED FOR YOUR PROTECTION” IS BROKEN OR MISSSING.

Warnings & Precautions
WARNINGS Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing swelling of tongue trouble speaking wheezing or problems breathing dizziness or loss of consciousness swelling in or around the mouth drooling The 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 injection 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 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. 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 breastfeeding: if breast-feeding: not recommended if pregnant: ask a health professional before use
Purpose

PURPOSE Antihistamine

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 of contact a Poison Control Center right away. (1-800-222-1222)


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