CHILDRENS ALLERGY- fexofenadine hydrochloride suspension 
Topco Associates LLC

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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
  • 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 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

Note: teaspoonful=tsp

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.

PRINCIPAL DISPLAY PANEL

TopCare®
non-drowsy
12 hour relief 
For Ages 2 Years
and Older

Children’s
Allergy 

FEXOFENADINE
HYDROCHLORIDE

INDOOR & OUTDOOR
ALLERGIES

12 Hour Relief of:

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

●  Alcohol Free 

Dye Free
Berry flavor 

Use only with enclosed dosing cup.
Wash and let air dry after each use. 

compare to Children’s Allegra® Allergy active ingredient* 

4 FL OZ (118 mL)

Childrens Allergy
CHILDRENS ALLERGY 
fexofenadine hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-715
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:36800-715-281 in 1 CARTON03/21/201606/30/2018
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20333003/21/201606/30/2018
Labeler - Topco Associates LLC (006935977)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2017
Document Id: c3db2399-7a22-446b-913a-13b784aa6fc4
Set id: 3d5410be-7ec0-438b-bf5a-4afd9bdc875d
Version: 4
Effective Time: 20171218
 
Topco Associates LLC