Cetirizine hydrochloride hives solution

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 immediatelyif 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 preventhives 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

Otc - ask doctor/pharmacist section


Ask a doctor or pharmacist before use if you aretaking 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 25C (68 to 77F) or store refrigerated, 2 to 8C (36 to 46F)

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 1-800-818-4555weekdays

Dist. by: Caraco Pharmaceutical Laboratories, Ltd.

Detroit, Michigan 48202

Mfg. by: SUN Pharmaceutical Industries, Inc.

Bryan, Ohio 43506


6027L01 Iss: 09/11

Ingredients and appearance - Product information

Cetirizine hydrochloride hives solution- Cetirizine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 57664-246
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Cetirizine hydrochloride ( UNII: 64O047KTOA)( Cetirizine - UNII: YO7261ME24 ) 1 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Acetic acid ( UNII: Q40Q9N063P)
Glycerin ( UNII: PDC6A3C0OX)
Methylparaben ( UNII: A2I8C7HI9T)
Water ( UNII: 059QF0KO0R)
Propylene glycol ( UNII: 6DC9Q167V3)
Propylparaben ( UNII: Z8IX2SC1OH)
Sodium acetate ( UNII: 4550K0SC9B)
Sucrose ( UNII: C151H8M554)

Product Characteristics

Color YELLOW (Colorless to slightly yellow) Flavor GRAPE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA091327 USA

Labeler - Sun Pharmaceutical Industries, Inc.( 146974886)

Principal display panel

NDC 57664-246-31

6 years&older

Childrens

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)