FDA Label for Allegra Hives 24hr

View Indications, Usage & Precautions

Allegra Hives 24hr Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet)



Fexofenadine HCl 180 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:

■ trouble swallowing ■ dizziness or loss of consciousness ■ swelling of tongue 

■ swelling in or around mouth ■ trouble speaking ■ wheezing or problems breathing ■ drooling

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



adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Other Information



■(if blister) safety sealed: do not use if carton is opened or if individual blister units are torn or opened

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

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

■ store between 20° and 25°C (68° and 77°F)

■ protect from excessive moisture


Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide


Questions Or Comments?



call toll-free 1-800-633-1610


Principal Display Panel



Allegra
Hives
fexofenadine HCI tablet
180 mg/antihistamine
24 HR
5 TABLETS

Allegra
Hives
fexofenadine HCI tablet
180 mg/antihistamine
24 HR
30 TABLETS


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