FEXOFENADINE HYDROCHLORIDE tablet, film coated

Fexofenadine hydrochloride by

Drug Labeling and Warnings

Fexofenadine hydrochloride by is a Otc medication manufactured, distributed, or labeled by AvPAK. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(in each tablet)

Fexofenadine HCl USP, 60 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper resporatory 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 aluminium or magnesium antacids
• do not take with fruit juices (see directions)

Stop use and ask 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

• 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 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 bottle is torn or missing
• store between 20°and 25°C (68°and 77°F)
• protect from excessive moisture and light

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,

Questions or comments?

 call 1-855-361-3993

Principal Display Panel

NDC: 50268-315-15
                       
Fexofenadine Hydrochloride Tablets USP
Antihistamine
60 mg
50 Tablets (5 x 10) Unit Dose
5026831515

NDC: 50268-315-15
                       
Fexofenadine Hydrochloride Tablets USP
Antihistamine
60 mg
50 Tablets (5 x 10) Unit Dose
5026831515

Drug Facts
Active ingredient Purpose
(in each tablet)
Fexofenadine HCl USP, 60 mg ............ 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

Drug Facts (continued)
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 care
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 take one 60 mg tablet with
12 years and over water every 12 hours; do not
take more than 2 tablets in
24 hours.
children under do not use
12 years of age
adults 65 years ask a doctor
of age and older
consumers with ask a doctor
kidney disease
Drug Facts (continued)
Other information
Store between 20° and 25°C (68° and 77°F)
Protect from excessive moisture and light
Inactive ingredients
anhydrous lactose, colloidal silicon dioxide, corn starch,
croscarmellose sodium, hypromellose, lactose
monohydrate, polyethylene glycol 400, pregelatinized
corn starch, red iron oxide, stearic acid, titanium
dioxide, and yellow iron oxide.
Questions? Call 1-855-361-3993

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. LM-2075 AV 07/17 (P)


                    

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50268-315(NDC:58602-710)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	orange (peach)	Score	no score
Shape	CAPSULE (Bevel Edge,Bioconvex)	Size	12mm
Flavor		Imprint Code	E;42
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50268-315-15	50 in 1 BOX, UNIT-DOSE	08/02/2017
1	NDC: 50268-315-11	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202039	08/02/2017

Labeler - AvPAK (832926666)