FEX-ALLERGY RELIEF- fexofenadine hcl tablet

Fex-Allergy Relief by

Drug Labeling and Warnings

Fex-Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Pioneer Life Sciences, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Fexofenadine hydrochloride USP, 180 mg

Purpose

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

Do not use:

Do not use

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

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)

ASK A DOCTOR BEFORE USE IF

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

STOP USE AND ASK A DOCTOR IF

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

If pregnant or breast-feeding

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 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

OTHER INFORMATION

• store at 20°-25°C (68°-77°F)
• protect from excessive moisture
• this product meets the requirement of USP dissolution test 2.

INACTIVE INGREDIENTS

colloidal silicon dioxide, corn starch,croscarmellose sodium, magnesium stearate,mannitol and microcrystalline cellulose, opadry pink 03B54504 containing FD and C red No.40, iron oxide black,hypromellose,polyethylene glycol, titanium dioxide.

QUESTIONS OR COMMENTS?

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

Keep out of reach of children.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FEX-ALLERGY RELIEF 
fexofenadine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72090-061
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
MANNITOL (UNII: 3OWL53L36A)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	J;44
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72090-061-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204097	09/21/2020

Labeler - Pioneer Life Sciences, LLC (014092742)