Cetirizine Hydrochloride HIVES

Dosage form: solution
Ingredients: CETIRIZINE HYDROCHLORIDE 1mg in 1mL
Labeler: Caraco Pharmaceutical Laboratories, Ltd
NDC Code: 57664-246

Drug Facts

Active Ingredient (in each 5 mL teaspoonful)
Cetirizine hydrochloride, USP 5mg

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

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 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 toll-free number 1-800-222-1222.

Directions
  •  use only with enclosed dosing cup
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 65 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 25ºC (68 to 77ºF) or store refrigerated, 2 to 8ºC (36 to 46ºF)

Inactive ingredients

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, purified water, propylene glycol, propylparaben, sodium acetate, and sucrose

Questions or comments?

call toll-free 1-800-818-4555 weekdays

Dist. by:      Caraco Pharmaceutical Laboratories, Ltd.

              Detroit, Michigan 48202

Mfg. by: SUN Pharmaceutical Industries, Inc.

              Bryan, Ohio 43506


6027L01                                          Iss: 09/11

Principal Display Panel

NDC 57664-246-31

6 years&older

Children’s

Cetirizine

Hydrochloride

1mg / mL Oral Solution, USP

 antihistamine

HIVES Relief

24 hour Relief of ITCHING

Due to Hives

Dosing Cup Included

Dosing cup should be washed and left to air dry after each use

Do not use if carton is opened, or if seal of bottle is broken or missing

6 years and older

Grape Syrup


4 fl. oz. (120 mL)
 
CETIRIZINE HYDROCHLORIDE HIVES 
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57664-246
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACETIC ACID 
GLYCERIN 
METHYLPARABEN 
WATER 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM ACETATE 
SUCROSE 
Product Characteristics
ColorYELLOW (Colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:57664-246-31120 mL in 1 BOTTLE
2NDC:57664-246-34470 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09132712/01/2011
Labeler - Caraco Pharmaceutical Laboratories, Ltd (146974886)
Registrant - Sun Pharmaceutical Industries Inc. (621283733)
Establishment
NameAddressID/FEIOperations
Sun Pharmaceutical Industries Inc.791055549MANUFACTURE, ANALYSIS

Revised: 10/2011
 
Caraco Pharmaceutical Laboratories, Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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