FEXOFENADINE HCL- fexofenadine hcl tablet, film coated 
Spirit Pharmaceuticals LLC

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ALLERGY RELIEF, 24 HR (FEXOFENADINE HCl TABLETS USP, 180 mg)

Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl 180 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
 runny nose  sneezing  itchy, watery eyes  itching of the nose or throat

Warnings

Do not use 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.

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. You may report side effects to FDA at 1-800-FDA-1088.

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 age do not use
 adults 65 years of age and older ask a doctor
 consumers with kidney disease ask a doctor

Drug Facts (continued)

Other information  safety sealed: do not use if printed foil inner
seal on bottle is torn or missing  store between 20º and 25ºC (68º
and 77ºF)  protect from excessive moisture

Inactive ingredients colloidal silicone dioxide, croscarmellose sodium, hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene
glycol/macrogol, povidone, pregelatinized starch, red iron oxide,
silica, titanium dioxide, yellow iron oxide.

Questions or comments? call +1-888-333-9792

PRINCIPAL DISPLAY PANEL

Allergy Relief
Fexofenadine HCl Tablets, 180 mg - Antihistamine

Indoor & Outdoor Allergies
• Sneezing • Runny Nose
• Itchy, Watery Eyes • Itchy Throat Or Nose

Non-Drowsy

4 tablets

image description

FEXOFENADINE HCL 
fexofenadine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4148
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colororange (ORANGE (PEACH)) Scoreno score
ShapeCAPSULESize17mm
FlavorImprint Code 180
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-4148-41 in 1 CARTON04/28/2021
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21013704/28/2021
Labeler - Spirit Pharmaceuticals LLC (179621011)

Revised: 12/2023
Document Id: 0c022a8b-a5df-04c7-e063-6294a90a1446
Set id: f0ea471e-de9f-4048-a48c-cfe858774854
Version: 4
Effective Time: 20231208
 
Spirit Pharmaceuticals LLC