Fexofenadine HCL by Safeway, Inc FEXOFENADINE HCL tablet

Fexofenadine HCL by

Drug Labeling and Warnings

Fexofenadine HCL by is a Otc medication manufactured, distributed, or labeled by Safeway, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingrdient (in each tablet)

Fexofenadine HCL Tablets, USP 180mg

Purpose

Antihistamine

Uses

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

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.

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 individual blister units are torn or opened ■ store between
20° and 25°C (68° and 77°F) ■ protect from excessive moisture

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?

contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

PDP

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL 
fexofenadine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-769
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	orange (Peach)	Score	no score
Shape	OVAL (Capsule-shaped)	Size	17mm
Flavor		Imprint Code	G6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-769-07	15 in 1 BLISTER PACK; Type 0: Not a Combination Product	11/06/2023
2	NDC: 21130-769-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211075	11/06/2023

Labeler - Safeway, Inc (009137209)