Active ingredient(s)

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

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

If pregnant or 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: take one 180 mg caplet with water, once a and over day; do not take more than 1 caplet 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, 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/Comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Principal Display Panel

Allergy Relief

ALLERGY RELIEF
allergy relief tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69168-450
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, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STARCH, CORN (UNII: O8232NY3SJ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69168-450-80	180 in 1 BOTTLE; Type 0: Not a Combination Product	04/17/2024
2	NDC:69168-450-82	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/17/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204097	04/17/2024

Labeler - Allegiant Health (079501930)

450 - Allergy Relief