CHILDRENS ALLERGY FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride suspension 
Actavis Pharma, Inc.

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Childrens Allergy Fexofenadine Hydrochloride Oral Suspension

Drug Facts

Active ingredient

(in each 5 mL)

Fexofenadine HCl, USP 30 mg

Purpose

Antihistamine

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.

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 over take 10 mL every 12 hours; do not take more than 20 mL in 24 hours
 children 2 to under 12 years of age take 5 mL  every 12 hours; do not take more than 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

Note: mL= milliliters

Other information

  • each 5 mL 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 20º to 25ºC (68º to 77ºF).
  • 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.

Principal Display Panel

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

NDC 0472-0527-94

NON-DROWSY
12 HOUR RELIEF

Ages 2 years and older

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

Antihistamine

Indoor/Outdoor Allergy Relief

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

Berry Flavor

Alcohol Free●Dye Free

4 FL OZ (118 mL)

Childrens Allergy Fexofenadine
CHILDRENS ALLERGY FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-0527
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:0472-0527-941 in 1 CARTON01/05/201505/31/2018
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20333001/05/201505/31/2018
Labeler - Actavis Pharma, Inc. (119723554)

Revised: 12/2017
 
Actavis Pharma, Inc.