Childrens cetirizine hydrochloride allergy solution

Drug facts

Active ingredient (in each 5 ml)


Cetirizine hydrochloride USP 5 mg

Purpose


Antihistamine

Uses


temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:


  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

Do not use


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.

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.

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 2 to under 6 years of age
teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 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,
2572 Brunswick 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 allergy solution- Cetirizine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-028
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( 58602-028), MANUFACTURE( 58602-028)

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


AUROHEALTH

NDC 58602-028-24

Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine ALLERGY
Indoor & Outdoor Allergies
24 hour
Relief of

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

2 yrs. & older
Cherry Flavor
Dye-Free

4 fl oz (120 mL)




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



AUROHEALTH

NDC 58602-028-24

Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL

antihistamine ALLERGY
Indoor & Outdoor Allergies
24 hour
Relief of

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

2 yrs. & older
Cherry Flavor
Dye-Free
4 fl oz (120 mL) Dosing Cup Included