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

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Childrens Allergy Relief

Wal-Mart Stores Inc

Equate 44-578


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each chewable tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Childrens Allergy Relief Uses

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

  • runny nose
  • itchy, watery eyes
  • sneezing
  • 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

  • drowsinness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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: no 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 enter (1-800-222-1222) right away.

Directions

  • may be taken with or without water
adults and children
6 years and over 
One 10 mg tablet once daily; do not take more than
one 10 mg tablet in 24 hours. A 5 mg product may
be appropriate for less severe symptoms 
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or
kidney disease
ask a doctor

Childrens Allergy Relief Other information

  • see end flap for expiration date and lot number
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store between 20º-25ºC (68º-77ºF)

Inactive ingredients

acesulfame potassium, artificial flavors, benzyl alcohol, betadex, colloidal silicon dioxide, dl-alpha-tocopherol, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, talc, tutti frutti flavor

Questions or comments?

Call 1-800-426-9391 8:30AM-4:00PM ET, Monday-Friday

Principal display panel

equate®

NDC 49035-578-02

Compare to Children's Zyrtec® Allergy Active Ingredient*

Ages 6+
Children's
Allergy Relief
Ceterizine HCl Chewable, 10 mg
Antihistamine

INDOOR &
OUTDOOR ALLERGIES

24 Hour Relief of:
• Sneezing • Runny Nose
• Itchy, Watery Eyes • Itchy Throat or Nose

Fruit Flavor

10 mg    12 CHEWABLE TABLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Zyrtec® Allergy.
50844    ORG031357802

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Childrens Allergy Relief
Equate 44-578

Childrens Allergy Relief

Cetirizine HCl TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49035-578
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 10 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
BENZYL ALCOHOL
betadex
SILICON DIOXIDE
.ALPHA.-TOCOPHEROL, DL-
ferric oxide red
FERRIC OXIDE YELLOW
lactose monohydrate
MAGNESIUM STEARATE
maltodextrin
cellulose, microcrystalline
propylene glycol
talc

Product Characteristics

Color Size Imprint Code Shape
YELLOW 10 mm SZ;106 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:49035-578-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077946 2008-10-31


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