Childrens Allergy Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Childrens Allergy Relief

Aurohealth LLC


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)


Cetirizine Hydrochloride USP 5 mg

Purpose


Antihistamine

Childrens Allergy Relief 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.

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 2 to under 6 years of age
  ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ 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

Childrens Allergy Relief Other information

  • store between 20° to 25°C (68° to 77°F)

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 Syrup is 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 if cap safety seal is broken or missing.

Distributed by:  AUROHEALTH LLC,
2572 Brunswick Pike,
Lawrenceville, NJ 08648
a division of Aurobindo Pharma USA, Inc.
6 Wheeling Road, Dayton NJ 08810

Made in INDIA

DRUGS/AP/19/1993

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL (120 mL Bottle)


AUROHEALTH
NDC 58602-422-12
*Compare to active ingredient in
Children's ZYRTEC®Allergy Syrup
Children's Allergy Relief
Cetirizine Hydrochloride
Oral Solution USP
1mg/mL
antihistamine
Indoor & Outdoor Allergies
24 hour relief of:

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


Grape Syrup
4 fl oz (120 mL)                2 yrs. & older

 Childrens Allergy Relief

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)


AUROHEALTH
NDC 58602-422-12
*Compare to active ingredient in
Children’s ZYRTEC® Allergy Syrup
Children's
Allergy Relief
Cetirizine
Hydrochloride
Oral Solution USP
1mg/mL

antihistamine
Indoor & Outdoor Allergies
24 hour Relief of

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

2 yrs. & older
Grape
Syrup
4 fl oz (120 mL)        Dosing Cup
                                     Included




Childrens Allergy Relief







Childrens Allergy Relief

Cetirizine Hydrochloride SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58602-422
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 1 mg

Inactive Ingredients

Ingredient Name Strength
ACETIC ACID
GLYCERIN
METHYLPARABEN
propylene glycol
PROPYLPARABEN
water
SODIUM ACETATE
SUCROSE

Product Characteristics

Color
YELLOW (Colorless to Pale Yellow)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 120 in 1 BOTTLE
2 240 in 1 BOTTLE
3 NDC:58602-422-20 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090750 2010-02-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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