Childrens allergy relief solution

Drug facts

Active ingredient (in each 5 ml teaspoonful)


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


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

Questions?


call 1-855-274-4122

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's ZYRTEC ®Allergy Syrup.Children's ZYRTEC ®Allergy Syrupis a registered trademark of UCB Pharma, S.A. Corporation Belgium

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

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

Distributed by:
AUROHEALTH LLC,
2572 Brunswick Pike,
Lawrenceville, NJ 08648

Made in INDIA

Code: TS/DRUGS/19/1993

Ingredients and appearance - Product information

Childrens allergy relief solution- Cetirizine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-424
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 GRAPE

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( 58602-424), MANUFACTURE( 58602-424)

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


NDC 58602-424-24

Primary Health
COMPARE TO Children's
ZYRTEC ®Allergy Syrup
Active ingredient*
Children's
Allergy Relief
Cetirizine Hydrochloride Oral Solution USP 1 mg/mL
antihistamine
Indoor & Outdoor Allergies
2 yrs. & older
24 hour relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchynose or throat


Dye-Free
Grape
Syrup
4FLOZ (120 mL)





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


NDC 58602-424-24
Primary Health
COMPARE TOChildrens
ZYRTEC ®Allergy Syrup
Active ingredient*
Children's
Allergy Relief
Cetirizine Hydrochloride
Oral Solution USP 1 mg/mL

antihistamine
Indoor & Outdoor Allergies

24 hour r elief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchynose or throat

2 yrs. & older
Dye-Free
Grape
Syrup
Dosing Cup Included


4FLOZ (120 mL)