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 useif 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
  • 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 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
1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 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 25 C (68 to 77F)

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

Distributed by:
Fred's,Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com


freds Promise Not Happy With This Product? Just Bring It Back For a Refund!


Ingredients and appearance - Product information

Childrens allergy relief solution- Cetirizine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 55315-354
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 - Fred's, Inc.( 005866116)

Establishment

Name ID/FEI Business Operations
Fred's, Inc. 005866116 MANUFACTURE( 55315-354)

Package label- principal display panel 4 fl oz (120 ml bottle)

NDC 55315-354-31

fred*s
KIDS ®
2 yrs & older

Children's
Allergy
Relief

Indoor & Outdoor
Allergies

Cetirizine Hydrochloride
Oral Solution, USP 1mg/mL
Antihistamine
Grape Flavored Syrup

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

Dosing Cup
Included

4
FL OZ (120 mL)
Compare to
*Children's ZYRTEC ®