Active ingredient(s)

Fexofenadine HCl 60mg

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 a doctor if

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

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

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

Directions

Adults and children 12 years of age and over: take one 60 mg caplet with water every 12 hours; do not take more than 2 caplets 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 room temperature 20°– 25°C (68°– 77°F)

protect from excessive moisture

do not use if imprinted seal under safety cap is broken or missing

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron
oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene
glycol, pregelatinized starch, purified water, titanium dioxide

Questions

Questions or comments?
Call 1-888-952-0050
Monday through Friday 9AM - 5PM

Principal Display Panel

Allergy Relief

ALLERGY RELIEF NON DROWSY
fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69168-437
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink (Peach)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	G5
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69168-437-98	200 in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2022
2	NDC:69168-437-06	120 in 1 BOTTLE; Type 0: Not a Combination Product	11/22/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211075	05/18/2022

Labeler - Allegiant Health (079501930)

437 - Allergy Relief