Fexofenadine Hydrochloride Tablets USP, 180 mg

Fexofenadine HCL by

Drug Labeling and Warnings

Fexofenadine HCL by is a Otc medication manufactured, distributed, or labeled by Denton Pharma, Inc. dba Northwind Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FEXOFENADINE HCL- fexofenadine hcl tablet 
Denton Pharma, Inc. dba Northwind Pharmaceuticals

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Fexofenadine Hydrochloride Tablets USP, 180 mg

ACTIVE INGREDIENT(S), in each tablet

Fexofenadine hydrochloride USP, 180 mg

PURPOSE

Antihistamine

USE(S)

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.

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

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







OTHER INFORMATION

  •  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

INACTIVE INGREDIENTS

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.

QUESTIONS OR COMMENTS

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

Principal Display Panel

NDC: 70934-601-30

label

FEXOFENADINE HCL 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70934-601(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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code J;44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70934-601-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/02/202002/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20409703/02/202002/28/2021
Labeler - Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)
Registrant - Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)
Establishment
NameAddressID/FEIBusiness Operations
Denton Pharma, Inc. dba Northwind Pharmaceuticals080355546repack(70934-601)

Revised: 1/2023
 
Denton Ph

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