FEXOFENADINE HCL 180 MG- fexofenadine hcl tablet

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts Active ingredient (in each tablet)

Fexofenadine HCl 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

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 professional before use.

Keep out of reach of children.

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

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

■ store between 20-25°C (68-77°F)
■ protect from excessive moisture
■ retain carton for complete product information and warnings

Inactive ingredients

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

Questions or comments?

855-280-1079

Principal Display Panel

NDC: 85786-204-30

DR. SIMI

Non-Drowsy
Allergy Relief

Fexofenadine HCl Tablets, 180 mg

Antihistamine

Indoor / Outdoor Allergy Relief ■ Sneezing ■ Runny Nose ■ Itchy, Watery Eyes ■ Itchy Nose or Throat

24 Hour

30 TABLETS

†Compare to the active ingredient in Allegra® 24 Hour

†This product is not manufactured or distributed by Chattem, Inc., distributor of Allegra® 24 Hour.

Made in India

Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
customerservice@drsimi.com
www.drsimi.com

Carton Labeling

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL 180 MG 
fexofenadine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85786-204
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	orange (Peach)	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	G6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85786-204-30	1 in 1 CARTON	04/08/2026
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211075	04/08/2026

Labeler - Farmacias De Similares TX LLC (119489934)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	manufacture(85786-204)

Establishment
Name	Address	ID/FEI	Business Operations
AAA Pharmaceutical, Inc.		181192162	pack(85786-204)