FEXOFENADINE HCL- fexofenadine hcl tablet 
CVS

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Allergy & Hives Relief
Fexofenadine HCL Tablets USP, 180mg
Antihistamine
reduces hives
relieves iching due to hives
Non- Drowsy

Active ingredient (in each tablet)

Fexofenadine HCl USP, 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.

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 every 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

 safety sealed: do not use if foil printed with granules logo under bottle cap is opened or torn.
 store between 20° and 25°C (68° and 77°F)
 protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide.

Principal display panel

30ct carton

FEXOFENADINE HCL 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-767
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
Colororange ((peach)) Scoreno score
ShapeCAPSULESize17mm
FlavorImprint Code G6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-767-0330 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21107503/27/2024
Labeler - CVS (062312574)

Revised: 3/2024
Document Id: 14cd724d-f096-3189-e063-6394a90a3ba5
Set id: 00ef8467-30a0-7579-e063-6294a90a75af
Version: 2
Effective Time: 20240329
 
CVS