Label: CHILDRENS ALLEGRA HIVES- fexofenadine hcl suspension
- NDC Code(s): 41167-4227-1
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated May 1, 2026
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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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)
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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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDRENS ALLEGRA HIVES
fexofenadine hcl suspensionProduct 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)
