CHILDRENS ALLEGRA HIVES- fexofenadine hcl suspension

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Children’s Allegra Hives 12 HR oral suspension - Grape Flavor

Drug Facts

Active ingredient

(in each 5 mL)                                 

Fexofenadine HCl 30 mg

Purpose

Antihistamine

Uses  

reduces hives and relieves itching due to hives (urticaria).

This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

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.

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 6 to under 12 years of age	take 5 mL every 12 hours; do not take more than 10 mL in 24 hours
children under 6 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: potassium 5 mg and sodium 19 mg

■ safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing

■ store between 20º and 25ºC (68º and 77ºF)

■ color change from white to beige is expected over time. This does not impact product effectiveness and safety.

Inactive ingredients   

edetate disodium, flavor, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucrose, titanium dioxide, xanthan gum, xylitol

Questions or comments?

call 1-866-844-2798

PRINCIPAL DISPLAY PANEL

NDC: 41167-4227-1
Childrens Allegra Hives

Grape Flavor
30 mg/5 mL antihistamine

Grape
12 HR
240 mL

INGREDIENTS AND APPEARANCE

CHILDRENS ALLEGRA HIVES 
fexofenadine hcl suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-4227
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-4227-1	1 in 1 CARTON	05/01/2026
1		240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA201373	05/01/2026

Labeler - Chattem, Inc. (003336013)