Childrens Allegra Hives Suspension
FDA Label NDC 41167-4227

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Childrens Allegra Hives (NDC 41167-4227). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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 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
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 20° and 25°C (68° and 77°F)

■ 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

Ndc 41167-4227-1childrens Allegra Hivesgrape Flavor30 mg/5 mL Antihistaminegrape12 Hr240 mL (Childrens Allegra Hives 01)

Ndc 41167-4227-1childrens Allegra Hivesgrape Flavor30 mg/5 mL Antihistaminegrape12 Hr240 mL (Childrens Allegra Hives 01)

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