Childrens cetirizine hydrochloride hives relief solution

Drug facts

Active ingredient (in each 5 ml)


Cetirizine hydrochloride USP5 mg

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

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 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. (1-800-222-1222)

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 nottake 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 under6 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)
  • Do not use if carton is opened, or if cap safety seal is broken or missing.

Inactive ingredients


cherry mint flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate trihydrate, sucrose

Questions?


call 1-855-274-4122

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

Do not use if carton is opened, or if cap safety seal is broken or missing.

Manufactured for:
AUROHEALTH LLC,
2572Brunswick Pike,
Lawrenceville, NJ 08648

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India

M.L.No.: 19/HD/AP/95/F/R

Ingredients and appearance - Product information

Childrens cetirizine hydrochloride hives relief solution- Cetirizine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-030
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)
Propylene glycol ( UNII: 6DC9Q167V3)
Propylparaben ( UNII: Z8IX2SC1OH)
Water ( UNII: 059QF0KO0R)
Sodium acetate ( UNII: 4550K0SC9B)
Sucrose ( UNII: C151H8M554)

Product Characteristics

Color YELLOW (Colorless to Pale Yellow) Flavor CHERRY (Cherry Mint)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA090750 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 ANALYSIS( 58602-030), MANUFACTURE( 58602-030)

Package label-principal display panel - 1 mg/ml (120 ml bottle)


AUROHEALTH
NDC 58602-030-24
Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine HIVES
Relief

24 hour
Relief of
ITCHING

Due to Hives
6yrs.
& older
Dye-Free
Cherry
Flavor
4 fl oz (120 mL)


Package label-principal display panel - 1 mg/ml carton (120 ml)


AUROHEALTH
NDC 58602-030-24
Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine HIVES
Relief

24 hour
Relief of
ITCHING

Due to Hives
6yrs.
& older
Dye-Free
Cherry
Flavor
4 fl oz (120 mL)
Dosing Cup Included