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: 70934-610-30

label

FEXOFENADINE HCL
fexofenadine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70934-610(NDC:69230-300)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	pink	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	J;44
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70934-610-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/13/2020	08/31/2023
2	NDC:70934-610-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/16/2020	03/31/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204097	03/13/2020	03/31/2024

Labeler - Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)

Registrant - Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)

Name	Address	ID/FEI	Business Operations
Establishment
Denton Pharma, Inc. dba Northwind Pharmaceuticals		080355546	repack(70934-610)

Revised: 1/2023

Document Id: f189414e-6e80-b37d-e053-2a95a90aa748

Set id: ab7132bc-e209-03f5-e053-2995a90a9953

Version: 2

Effective Time: 20230105

Denton Pharma, Inc. dba Northwind Pharmaceuticals