CHILDRENS ALLERGY FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride suspension 
Preferred Plus (Kinray)

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Childrens Allergy Fexofenadine Hydrochloride Oral Suspension

Drug Facts

Active ingredient

(in each 5 mL = 1 teaspoonful)

Fexofenadine HCl, USP 30 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.

Ask a doctor before use if you have

kidney disease. Your doctor should determine if you need a different dose.

When using this product:

  • do not take more than directed
  • do not take at the same time as aluminum or magnesium antacids
  • do not take with fruit juices (see Directions)

Stop use and ask a doctor if 

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

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

  • shake well before using
  • use only with enclosed dosing cup
 adults and children 12 years of age and overtake 2 teaspoonfuls (10 mL) every 12 hours; do not take more than 4 teaspoonfuls (20 mL) in 24 hours 
 children 2 to under 12 years of age take 1 teaspoonful (5 mL) every 12 hours; do not take more than 2 teaspoonfuls (10 mL) in 24 hours
 children under 2 years of age ask a doctor
 adults 65 years of age and older ask a doctor
 consumers with kidney disease ask a doctor

Other information

• each 5 mL (1 teaspoonful) contains: sodium 18 mg
• safety sealed: do not use if carton, unprinted foil inner seal, or neckband printed with “SEALED FOR YOUR PROTECTION” is opened, torn or missing.
•store between 20° to 25°C (68° to 77°F).
•before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients  

artificial raspberry flavor, butylparaben, edetate disodium, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sucrose, titanium dioxide, xanthan gum, xylitol

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61715-136-04

Compare to the active ingredient in Children’s Allegra® Allergy  

Preferred Plus Pharmacy 

Ages 2 years and older 

NON-DROWSY
12 HOUR RELIEF        

Children’s Allergy
Fexofenadine Hydrochloride Oral Suspension
30 mg/ 5mL 

Antihistamine
Indoor and Outdoor Allergies
12 Hour Relied of:

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

Berry Flavor
Alcohol Free
Dye Free

4 fl. oz. (118 mL)

fexo childrens allergy label
CHILDRENS ALLERGY FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-136
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
Other Ingredients
Ingredient KindIngredient NameQuantity
Does not containALCOHOL (UNII: 3K9958V90M) 0   in 5 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-136-041 in 1 CARTON03/01/201512/31/2017
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20333003/01/201512/31/2017
Labeler - Preferred Plus (Kinray) (012574513)

Revised: 12/2017
Document Id: ebeec0f8-65d4-4ddb-800a-bc184f63a0e7
Set id: d0b353f3-c26c-43ef-b318-a9b91334c0ff
Version: 4
Effective Time: 20171222
 
Preferred Plus (Kinray)