ALLEGRA HIVES 24HR- fexofenadine hydrochloride tablet, film coated

Allegra Hives 24hr by

Drug Labeling and Warnings

Allegra Hives 24hr by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Allegra Hives 24HR tablet 180 mg

Drug Facts

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 over: take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
• children under 12 years of age: do not use
• adults 65 years of age and older: ask a doctor
• consumers with kidney disease: ask 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
30 TABLETS

INGREDIENTS AND APPEARANCE

ALLEGRA HIVES 24HR 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-4126
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (peach)	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	018;E
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-4126-8	1 in 1 CARTON	06/06/2022
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-4126-3	1 in 1 CARTON	01/31/2024
2		15 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 41167-4126-4	1 in 1 CARTON	06/06/2022
3		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020872	06/06/2022

Labeler - Chattem, Inc. (003336013)