FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet
REMEDYREPACK INC.

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Fexofenadine HCl Tablets USP

Active ingredient(s)

Fexofenadine HCl USP, 30 mg

Fexofenadine HCl USP, 60 mg

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Use(s)

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

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 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 printed foil inner seal on bottle is torn or missing
store between 20° and 25°C (68° and 77°F)
protect from excessive moisture
this product meets the requirements of USP Dissolution Test 4

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide

Questions?

Call 1-888-375-3784

PRINCIPAL DISPLAY PANEL

DRUG: Fexofenadine hydrochloride

GENERIC: Fexofenadine hydrochloride

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2971-0

NDC: 70518-2971-1

COLOR: pink

SHAPE: OVAL

SCORE: No score

SIZE: 7 mm

IMPRINT: 194;R

PACKAGING: 100 in 1 BOTTLE, PLASTIC

PACKAGING: 30 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

Fexofenadine Hydrochloride 180mg in 1

INACTIVE INGREDIENT(S):

SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MANNITOL
POWDERED CELLULOSE
FD&C RED NO. 40
HYPROMELLOSE 2910 (6 MPA.S)
FERROSOFERRIC OXIDE
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
STARCH, CORN

MM1

MM2

FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-2971(NDC:55111-784)
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)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	7mm
Flavor		Imprint Code	194;R
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70518-2971-0	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/16/2020
2	NDC:70518-2971-1	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076502	12/16/2020

Labeler - REMEDYREPACK INC. (829572556)

Revised: 11/2022

Document Id: ece61a7f-5ed4-8cd4-e053-2995a90afb3f

Set id: a82c6918-2fbf-4db8-b3d6-2efef28b3d49

Version: 6

Effective Time: 20221107

REMEDYREPACK INC.