CHILDRENS ALLERGY FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride suspension 
Rugby Laboratories

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Childrens Allergy Fexofenadine Hydrochloride Oral Suspension

Drug Facts

Active ingredient

(in each 5 mL= 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 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 agetake 1 teaspoonful (5 mL) every 12 hours; do not take more than 2 teaspoonfuls(10 mL) in 24 hours
children under 2 years of ageask a doctor
adults 65 years of age and olderask a doctor
consumers with kidney disease

ask a doctor

Note: teaspoonful = tsp

Other information


  • each 5 mL (1 teaspoon) 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 0536-1005-97

Rugby® 

Ages 2 years and older
Children’s Allergy
Fexofenadine Hydrochloride Oral Suspension
30 mg per 5mL
Antihistamine

Indoor and Outdoor Allergies

12 Hour Relief of:

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

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

Berry Flavor
Alcohol Free
Dye Free 

NON-DROWSY

4 fl. oz. (118 mL)

image
CHILDRENS ALLERGY FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1005
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:0536-1005-971 in 1 CARTON12/19/201406/30/2018
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20333012/19/201406/30/2018
Labeler - Rugby Laboratories (079246066)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 11/2017
Document Id: b1637c15-6a9a-40cb-b42d-697c5985523f
Set id: c5f2ac86-b6be-486d-b1d3-7704f56c3245
Version: 5
Effective Time: 20171129
 
Rugby Laboratories