FEXOFENADINE HCL- fexofenadine hcl tablet 
Safeway, Inc

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Fexofenadine Hydrochloride Tablets, USP 180mg

Allergy Relief
Non-Drowsy

Antihistamine
Indoor/Outdoor Allergy Relief

■ Sneezing
■ Runny Nose
■ Itchy, Watery Eyes
■ Itchy Nose or Throat

Active Ingrdient (in each tablet)

Fexofenadine HCL Tablets, USP 180mg

Purpose

Antihistamine

Uses

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

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.

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

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

Questions or comments?

contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

PDP

Fexo 180mgFexo 180mg

FEXOFENADINE HCL 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-769
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
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colororange (Peach) Scoreno score
ShapeOVAL (Capsule-shaped) Size17mm
FlavorImprint Code G6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-769-0715 in 1 BLISTER PACK; Type 0: Not a Combination Product11/06/2023
2NDC:21130-769-0330 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21107511/06/2023
Labeler - Safeway, Inc (009137209)

Revised: 12/2023
Document Id: 0ccfe788-9681-211b-e063-6394a90a6100
Set id: f32e9cb6-af93-e60a-e053-2995a90a42f5
Version: 3
Effective Time: 20231218
 
Safeway, Inc