CHILDRENS FEXOFENADINE HYDROCHLORIDE  HIVES- fexofenadine hydrochloride suspension 
Taro Pharmaceuticals U.S.A., Inc.


Children's Fexofenadine Hydrochloride

Drug Facts

Active ingredient (in each 5 mL)

Fexofenadine HCI 30 mg




reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.


Severe Allergy Warning

Get emergency help immediately if you have hives along with any of the following symptoms:

  • swelling of tongue
  • trouble swallowing
  • swelling in or around mouth
  • trouble speaking
  • wheezing or problems breathing
  • drooling
  • dizziness or loss of consciousness

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

  • to prevent hives from any known cause such as:
    • foods
    • insect stings
    • medicines
    • latex or rubber gloves
    because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
  • 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.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

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.
  • symptoms do not improve after 3 days of treatment
  • the hives have lasted more than 6 weeks

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.


  • shake well before using
  • use only with enclosed dosing cup
Note: mL = milliliters
adults and children 12 years of age and overtake 10 mL every 12 hours; do not take more than 20 mL in 24 hours
children 6 to under 12 years of agetake 5 mL every 12 hours; do not take more than 10 mL in 24 hours
children under 6 years of ageask a doctor
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

  • each 5 mL contains: sodium 9 mg
  • safety sealed: do not use if carton is opened or if foil inner seal on bottle is torn or missing
  • store between 20° and 25°C (68° and 77°F)

Inactive ingredients

artificial raspberry flavor, butylparaben, edetate disodium, maltitol solution, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucralose, titanium dioxide and xanthan gum


Call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532


Compare to the active
ingredient in Children's
Allegra® Hives*

NDC 51672-2121-8

Fexofenadine HCI
Oral Suspension,
30 mg/ 5 mL



Berry Flavor

Ages 6 Years
& Older


Dye free / Alcohol free / Sugar free

Oral Suspension

4 fl. oz.
(120 mL)

Principal Display Panel - 120 mL Bottle Carton
fexofenadine hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2121
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)  
maltitol (UNII: D65DG142WK)  
poloxamer 407 (UNII: TUF2IVW3M2)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
sodium phosphate, dibasic, heptahydrate (UNII: 70WT22SF4B)  
sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN)  
sucralose (UNII: 96K6UQ3ZD4)  
titanium dioxide (UNII: 15FIX9V2JP)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
FlavorRASPBERRYImprint Code
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-2121-41 in 1 CARTON11/09/201711/17/2023
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51672-2121-81 in 1 CARTON11/09/201711/17/2023
2120 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:51672-2121-11 in 1 CARTON11/09/201711/17/2023
3240 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Revised: 11/2023
Taro Pharmaceuticals U.S.A., Inc.