FEXOFENADINE- fexofenadine tablet 
DirectRx

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Fenofenadine

Fexofenadine hydrochloride USP, 180 mg

Antihistamine

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

if you have ever had an allergic reaction to this product or any of its ingredients.

you have kidney disease. Your doctor should determine if you need a different dose.

§ 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)

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

60 mg


adults and children 12 years of age and over
take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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


180 mg


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


 Safety Sealed: do not use if carton is opened or if printed foil inner seal on the bottle is torn or missing.
 store between 20° and 25°C (68° and 77°F)
 protect from excessive moisture

Colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418

hi

FEXOFENADINE 
fexofenadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72189-305(NDC:69230-300)
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)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code J;44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72189-305-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/17/202110/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20409712/17/202110/09/2023
Labeler - DirectRx (079254320)
Registrant - DirectRx (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DirectRx079254320repack(72189-305)

Revised: 10/2023
 
DirectRx